Trial Outcomes & Findings for A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures (NCT NCT01618695)

NCT ID: NCT01618695

Last Updated: 2021-07-29

Results Overview

Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

940 participants

Primary outcome timeframe

Baseline, Week 19

Results posted on

2021-07-29

Participant Flow

Participants took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand from 15th May 2012 to 28th May 2020. A total of 940 participants were enrolled and screened, of which 230 participants were screen failures, 710 participants were randomized and 707 participants were treated in this study.

This study included Core and Extension Phase. Core Phase consisted of 2 phases: Prerandomization (Baseline) and Randomization (Titration, Maintenance Period). Extension Phase consisted of 3 periods: Preconversion, Conversion, Maintenance Period. Participants received varying doses depending on which dose level they were assigned to in Core Phase and their individual tolerance but in Extension Phase, all participants were up-titrated to single target dose level of 12 milligram (mg) per day.

Participant milestones

Participant milestones
Measure
Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks) in the Core Phase. Participants received placebo in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 2 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally, once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period in Core Phase was 19 weeks. Participants received the same dose of perampanel 4 mg in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 4 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally, once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 8 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 8 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase/Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally, once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 12 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period) and continued receiving perampanel 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase
STARTED
177
176
177
180
Core Phase
Treated (Safety Analysis Set)
176
176
175
180
Core Phase
COMPLETED
152
156
147
144
Core Phase
NOT COMPLETED
25
20
30
36
Extension Phase
STARTED
151
156
146
143
Extension Phase
COMPLETED
56
40
54
46
Extension Phase
NOT COMPLETED
95
116
92
97

Reasons for withdrawal

Reasons for withdrawal
Measure
Core Phase: Placebo; Extension Phase: up to 12 mg Perampanel
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks) in the Core Phase. Participants received placebo in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 2 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase: Perampanel 4 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally, once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period in Core Phase was 19 weeks. Participants received the same dose of perampanel 4 mg in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 4 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase: Perampanel 8 mg; Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally, once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 8 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). Participants started receiving perampanel 8 mg tablet, orally, once daily which was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase/Extension Phase: up to 12 mg Perampanel
Participants received perampanel 2 mg tablet, orally, once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally, once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally, once daily from Week 6 up to Week 18 (maintenance period) in the Core Phase. Total duration of titration and maintenance period was 19 weeks in the Core Phase. Participants received the same dose of perampanel 12 mg in the Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period) and continued receiving perampanel 12 mg, orally, once daily up to Week 28 (conversion period). All participants could have their dose down or up titrated until an optimal dose was reached. After the conversion period, participants entered a maintenance period in which they received the perampanel dose orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country in the Extension Phase.
Core Phase
Adverse Event
4
5
15
20
Core Phase
Lost to Follow-up
0
0
1
0
Core Phase
Withdrawal by Subject
16
11
9
13
Core Phase
Pregnancy
2
0
0
0
Core Phase
Lack of Efficacy
1
2
1
1
Core Phase
Other than specified
1
2
2
2
Core Phase
Not treated
1
0
2
0
Extension Phase
Lack of Efficacy
17
33
26
24
Extension Phase
Pregnancy
2
0
1
1
Extension Phase
Withdrawal by Subject
43
48
42
33
Extension Phase
Adverse Event
18
16
9
20
Extension Phase
Lost to Follow-up
2
1
1
1
Extension Phase
Other than specified
13
18
13
18

Baseline Characteristics

A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Core Phase: Placebo
n=176 Participants
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Core Phase: Perampanel 4 mg
n=176 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 8 mg
n=175 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 12 mg
n=180 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Total
n=707 Participants
Total of all reporting groups
Age, Continuous
34.5 years
STANDARD_DEVIATION 13.21 • n=5 Participants
33.1 years
STANDARD_DEVIATION 13.18 • n=7 Participants
33.6 years
STANDARD_DEVIATION 14.11 • n=5 Participants
32.3 years
STANDARD_DEVIATION 12.30 • n=4 Participants
33.4 years
STANDARD_DEVIATION 13.21 • n=21 Participants
Sex: Female, Male
Female
90 Participants
n=5 Participants
94 Participants
n=7 Participants
84 Participants
n=5 Participants
93 Participants
n=4 Participants
361 Participants
n=21 Participants
Sex: Female, Male
Male
86 Participants
n=5 Participants
82 Participants
n=7 Participants
91 Participants
n=5 Participants
87 Participants
n=4 Participants
346 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
176 Participants
n=5 Participants
175 Participants
n=7 Participants
175 Participants
n=5 Participants
179 Participants
n=4 Participants
705 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
169 Participants
n=5 Participants
168 Participants
n=7 Participants
159 Participants
n=5 Participants
171 Participants
n=4 Participants
667 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
7 Participants
n=4 Participants
35 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
4 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 19

Population: Intent-to-treat (ITT) Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.

Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

Outcome measures

Outcome measures
Measure
Placebo
n=175 Participants
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Perampanel 4 mg
n=174 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 8 mg
n=175 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 12 mg
n=180 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
-10.76 percent change
Interval -90.4 to 400.0
-17.32 percent change
Interval -97.1 to 473.4
-28.95 percent change
Interval -100.0 to 809.4
-38.03 percent change
Interval -100.0 to 456.8

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.

Responder rate was percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\<) 50%, then the participants are considered as non-responders.

Outcome measures

Outcome measures
Measure
Placebo
n=175 Participants
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Perampanel 4 mg
n=174 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 8 mg
n=175 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 12 mg
n=180 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
19.4 percentage of participants
23.0 percentage of participants
36.0 percentage of participants
43.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.

Outcome measures

Outcome measures
Measure
Placebo
n=158 Participants
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Perampanel 4 mg
n=151 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 8 mg
n=157 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 12 mg
n=167 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
-11.70 percent change
Interval -88.6 to 400.0
-19.08 percent change
Interval -100.0 to 410.0
-33.68 percent change
Interval -100.0 to 1103.4
-41.80 percent change
Interval -100.0 to 456.8

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one postdose seizure frequency data.

The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.

Outcome measures

Outcome measures
Measure
Placebo
n=175 Participants
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Perampanel 4 mg
n=174 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 8 mg
n=175 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Perampanel 12 mg
n=180 Participants
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Very much improved
3 Participants
5 Participants
11 Participants
9 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Much improved
31 Participants
39 Participants
41 Participants
54 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Minimally improved
54 Participants
45 Participants
53 Participants
40 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
No change
67 Participants
56 Participants
37 Participants
37 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Minimally worse
3 Participants
10 Participants
5 Participants
4 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Much worse
1 Participants
0 Participants
0 Participants
1 Participants
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Very much worse
0 Participants
0 Participants
0 Participants
1 Participants

Adverse Events

Core Phase: Placebo

Serious events: 10 serious events
Other events: 114 other events
Deaths: 1 deaths

Core Phase: Perampanel 4 mg

Serious events: 6 serious events
Other events: 119 other events
Deaths: 0 deaths

Core Phase: Perampanel 8 mg

Serious events: 7 serious events
Other events: 127 other events
Deaths: 1 deaths

Core Phase: Perampanel 12 mg

Serious events: 12 serious events
Other events: 155 other events
Deaths: 0 deaths

Extension Phase: Perampanel 12 mg

Serious events: 113 serious events
Other events: 618 other events
Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure
Core Phase: Placebo
n=176 participants at risk
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Core Phase: Perampanel 4 mg
n=176 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 8 mg
n=175 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 12 mg
n=180 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Extension Phase: Perampanel 12 mg
n=679 participants at risk
Participants received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Participants who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). All participants were allowed to have their dose down or up titrated until an optimal dose was reached. A maintenance period was followed by conversion period in which participants received perampanel dose of 12 mg, orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Death
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Sudden cardiac death
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Anal abscess
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Cellulitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pneumonia
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pyelonephritis acute
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Renal abscess
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Brain contusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Burns second degree
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Facial bones fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Contusion
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Epilepsy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Status epilepticus
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Complex partial seizures
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Convulsion
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Partial seizures with secondary generalisation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Grand mal convulsion
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Aggression
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Suicide attempt
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Acute psychosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Conversion disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Self-injurious ideation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Adenomyosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Excessive granulation tissue
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Surgical and medical procedures
Abortion induced
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Aneurysm
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Thrombophlebitis superficial
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Emotional disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Pregnancy, puerperium and perinatal conditions
Pregnancy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Sudden unexplained death in epilepsy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Anxiety
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Anxiety disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Bipolar disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Delusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Hallucination, auditory
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Irritability
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mental disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Postictal psychosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Psychogenic seizure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Psychotic disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Psychotic disorder due to a general medical condition
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Suicidal behaviour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Fibula fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Head injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Intentional overdose
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ligament injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Meniscus injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Patella fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Pelvic fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Acute myocardial infarction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Myocardial infarction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Sinus node dysfunction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Asphyxia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Altered state of consciousness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Ataxia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Cerebral infarction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Cerebrovascular accident
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dizziness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dysarthria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Focal dyscognitive seizures
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Generalised tonic-clonic seizure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Idiopathic partial epilepsy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Lacunar infarction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Limbic encephalitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Normal pressure hydrocephalus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Seizure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Seizure cluster
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Somnolence
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Subarachnoid haemorrhage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Cataract
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Lens dislocation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Diarrhoea
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Enterocolitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival hypertrophy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Haematemesis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Urinary retention
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Appendicitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gastroenteritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Herpes zoster
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Lung infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Nasopharyngitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Periodontitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pharyngitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Post procedural infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Sepsis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Urinary tract infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.

Other adverse events

Other adverse events
Measure
Core Phase: Placebo
n=176 participants at risk
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Core Phase: Perampanel 4 mg
n=176 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 8 mg
n=175 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Core Phase: Perampanel 12 mg
n=180 participants at risk
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Extension Phase: Perampanel 12 mg
n=679 participants at risk
Participants received the same dose of perampanel in Extension Phase as they received in Core Phase, orally, once daily before bedtime from Week 19 to Week 22 (preconversion period). This dose was then titrated as 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). Participants who received perampanel matched-placebo in Core Phase were given perampanel 2 mg weekly increments up to a maximum dose of 12 mg, orally once daily up to Week 28 (conversion period). All participants were allowed to have their dose down or up titrated until an optimal dose was reached. A maintenance period was followed by conversion period in which participants received perampanel dose of 12 mg, orally, once daily, that provided the optimal combination of efficacy and tolerability before bedtime up to Week 75 or longer depending on the requirements of each country.
Eye disorders
Cataract
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Chalazion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Anaemia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Lymphadenitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Angina pectoris
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Atrial fibrillation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Vertigo
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
5/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
23/679 • Number of events 25 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Cerumen impaction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Tinnitus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Vision blurred
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Asthenopia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Conjunctivitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Diplopia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.6%
11/679 • Number of events 12 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Eyelid oedema
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Visual impairment
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Conjunctival haemorrhage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Dry eye
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Dysmetropsia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Glaucoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Keratoconjunctivitis sicca
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Normal tension glaucoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Retinal disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Vitreous floaters
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Eye pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Lacrimation increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Nausea
3.4%
6/176 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.6%
10/180 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.2%
35/679 • Number of events 37 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Diarrhoea
3.4%
6/176 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.3%
6/180 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.9%
33/679 • Number of events 42 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Stomatitis
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
5/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.7%
25/679 • Number of events 35 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Constipation
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
5/175 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.0%
27/679 • Number of events 36 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Vomiting
4.0%
7/176 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.5%
24/679 • Number of events 25 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Abdominal discomfort
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.6%
11/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Abdominal pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.9%
13/679 • Number of events 15 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Dyspepsia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/175 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.6%
11/679 • Number of events 11 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gastritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Toothache
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.5%
10/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Cheilitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Dental caries
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
23/679 • Number of events 25 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gingivitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Abdominal pain upper
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Aphthous stomatitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Colonic polyp
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Crohn's disease
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival hyperplasia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival ulceration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Oral disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Oral pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Periodontal disease
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Reflux oesophagitis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Salivary hypersecretion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Dry mouth
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Enteritis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Epigastric discomfort
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gastritis atrophic
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Lip dry
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Periodontitis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Irritability
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.5%
8/176 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.7%
10/175 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.0%
9/180 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Fatigue
2.8%
5/176 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
6/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.0%
9/180 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.0%
34/679 • Number of events 36 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Gait disturbance
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.0%
9/180 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.1%
28/679 • Number of events 34 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Pyrexia
1.7%
3/176 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.7%
39/679 • Number of events 90 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Asthenia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.5%
17/679 • Number of events 20 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Malaise
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Feeling abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Device breakage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Face oedema
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Foreign body reaction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Influenza like illness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Oedema
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Chest discomfort
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Cholecystitis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Immune system disorders
Allergy to arthropod sting
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Immune system disorders
Seasonal allergy
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Nasopharyngitis
14.8%
26/176 • Number of events 26 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
13.1%
23/176 • Number of events 23 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
13.7%
24/175 • Number of events 30 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
12.8%
23/180 • Number of events 28 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
25.0%
170/679 • Number of events 325 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Upper respiratory tract infection
4.5%
8/176 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.5%
8/176 • Number of events 12 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
8.0%
14/175 • Number of events 17 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
6.1%
11/180 • Number of events 19 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
10.3%
70/679 • Number of events 147 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pharyngitis
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.5%
24/679 • Number of events 36 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Influenza
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.6%
31/679 • Number of events 36 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gastroenteritis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.7%
18/679 • Number of events 20 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Tinea pedis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Bronchitis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gastroenteritis viral
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Oral herpes
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Rhinitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Bacterial infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gastroenteritis bacterial
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Herpes zoster
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Impetigo
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Otitis externa
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Otitis media
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pneumonia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Purulence
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Respiratory tract infection
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Sinusitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Syphilis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Tonsillitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Urinary tract infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Viral infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Wound infection
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Eczema infected
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Onychomycosis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Contusion
2.3%
4/176 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.8%
5/176 • Number of events 19 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
6/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.8%
5/180 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
7.2%
49/679 • Number of events 81 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Joint sprain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Excoriation
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Foot fracture
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Skin laceration
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.1%
21/679 • Number of events 21 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.1%
14/679 • Number of events 15 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Wound
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Animal bite
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Fall
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.1%
14/679 • Number of events 20 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Head injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.6%
11/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Lip injury
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Rib fracture
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ankle fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Burns second degree
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Heat stroke
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Joint dislocation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ligament rupture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Multiple injuries
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Periorbital haematoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Stab wound
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Sunburn
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Tibia fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Tooth injury
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Forearm fracture
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Scratch
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Weight increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.0%
7/176 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
6/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.3%
6/180 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.9%
40/679 • Number of events 44 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood creatine phosphokinase increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.8%
5/180 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.5%
24/679 • Number of events 32 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Electrocardiogram QT prolonged
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood phosphorus decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Protein urine present
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 14 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Weight decreased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.9%
13/679 • Number of events 14 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood cholesterol increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood uric acid increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Gamma-glutamyltransferase increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
White blood cell count decreased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Alanine aminotransferase increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Aspartate aminotransferase increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood parathyroid hormone abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood sodium decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood triglycerides abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Eosinophil count increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Monocyte count increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Neutrophil count decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Platelet count decreased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Red blood cells urine
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Urine ketone body present
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Vitamin D decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood glucose increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood triglycerides increased
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood urine present
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Decreased appetite
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
5/175 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.1%
21/679 • Number of events 21 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.5%
10/679 • Number of events 12 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Increased appetite
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Dyslipidaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/175 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypochloraemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Dehydration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Weight fluctuation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Appetite disorder
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyperglycaemia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Back pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
20/679 • Number of events 22 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Myalgia
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.5%
10/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Pain in extremity
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.1%
14/679 • Number of events 15 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Monarthritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Muscle twitching
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Myokymia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Tenosynovitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Flank pain
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Neck pain
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Osteoarthritis
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dizziness
5.7%
10/176 • Number of events 11 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
22.7%
40/176 • Number of events 48 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
28.6%
50/175 • Number of events 60 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
42.2%
76/180 • Number of events 85 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
46.7%
317/679 • Number of events 435 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Somnolence
13.1%
23/176 • Number of events 24 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
15.9%
28/176 • Number of events 28 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
17.7%
31/175 • Number of events 36 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
17.8%
32/180 • Number of events 33 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
24.3%
165/679 • Number of events 199 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Headache
7.4%
13/176 • Number of events 18 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
6.8%
12/176 • Number of events 22 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
7.4%
13/175 • Number of events 14 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.6%
10/180 • Number of events 11 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
13.8%
94/679 • Number of events 164 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Ataxia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.9%
7/180 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.2%
22/679 • Number of events 26 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Balance disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.5%
17/679 • Number of events 18 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dysarthria
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/175 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.2%
22/679 • Number of events 24 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Hypoaesthesia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 17 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Tremor
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.8%
19/679 • Number of events 23 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Convulsion
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Memory impairment
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.1%
14/679 • Number of events 16 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Nystagmus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Amnesia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Complex partial seizures
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dementia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Lethargy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Paraesthesia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Aphasia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Clumsiness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Cranial nerve disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dizziness postural
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dysaesthesia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dyskinesia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dystonia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Head discomfort
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Hypersomnia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Migraine
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Myoclonus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Nerve root compression
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Psychomotor hyperactivity
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Sensory disturbance
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Anaesthesia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dyslalia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Grand mal convulsion
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Partial seizures with secondary generalisation
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Syncope
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Tongue biting
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Pregnancy, puerperium and perinatal conditions
Pregnancy
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Aggression
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.9%
5/175 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.2%
4/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.2%
22/679 • Number of events 24 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Suicidal ideation
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.0%
7/175 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.1%
21/679 • Number of events 28 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Anxiety
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
6/175 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.2%
22/679 • Number of events 22 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Insomnia
4.0%
7/176 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.7%
25/679 • Number of events 27 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mood swings
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.8%
12/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Anger
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.7%
3/180 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Depression
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.4%
16/679 • Number of events 19 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Affect lability
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Depressed mood
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Abnormal behaviour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Hallucination, auditory
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mood altered
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Sleep disorder
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 8 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Affective disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Agitation
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Anxiety disorder
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Confusional arousal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Emotional disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Expressive language disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Fear
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Impatience
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Nervousness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Obsessive-compulsive disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Personality change
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Personality disorder
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Regressive behaviour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Restlessness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Self-injurious ideation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Sleep talking
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Soliloquy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Stubbornness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Suicide attempt
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Thinking abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Tic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Abnormal dreams
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Acute stress disorder
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Intentional self-injury
0.57%
1/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Panic attack
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Dysuria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Bladder irritation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Calculus ureteric
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Hypertonic bladder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Neurogenic bladder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Nocturia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Polyuria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Proteinuria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Urinary incontinence
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Haematuria
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Pollakiuria
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Prostatitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Cervical cyst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Cervical polyp
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Hypomenorrhoea
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Menstrual disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Menstruation irregular
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Pelvic fluid collection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Scrotal swelling
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Dysmenorrhoea
0.57%
1/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.9%
13/679 • Number of events 15 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 10 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Cough
1.1%
2/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
1.7%
3/176 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.3%
9/679 • Number of events 11 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Rash
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/175 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
5.0%
9/180 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
4.6%
31/679 • Number of events 37 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Pruritus
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.3%
4/175 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.9%
13/679 • Number of events 16 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Eczema
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.7%
18/679 • Number of events 20 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dermatitis
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.9%
13/679 • Number of events 13 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Urticaria
2.3%
4/176 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/180 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.2%
8/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Heat rash
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.0%
7/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 9 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.88%
6/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Eczema asteatotic
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Erythema
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Pityriasis alba
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin erosion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/175 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Alopecia
1.7%
3/176 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Night sweats
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Hypertension
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Hypotension
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.56%
1/180 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Angiodysplasia
0.57%
1/176 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Bone contusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Bone fissure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Burns first degree
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Chemical poisoning
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Chest injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Chillblains
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Closed globe injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Concussion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Conjunctival abrasion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ear canal abrasion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Eye contusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Eye injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Eyelid contusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Eyelid injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Face injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Heat illness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Joint injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ligament injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
3.4%
23/679 • Number of events 24 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Mouth injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Neck injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Patella fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Scar
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.4%
16/679 • Number of events 18 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Skin injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Skin wound
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Soft tissue injury
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Subcutaneous haematoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Tooth dislocation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Anticonvulsant drug level increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood bicarbonate decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood bilirubin increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood creatinine decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood lactate dehydrogenase increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood magnesium abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood phosphorus increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood pressure increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Blood sodium increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Gamma-glutamyltransferase abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Liver function test abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Liver function test increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Lymphocyte count decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Neutrophil count increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Red blood cell count decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Red blood cells urine positive
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Thyroxine free decreased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
Urine uric acid increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
White blood cell count increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Investigations
pH urine increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Arteriosclerosis coronary artery
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Palpitations
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Cardiac disorders
Tachycardia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Congenital, familial and genetic disorders
Hypophosphatasia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Neutrophilia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Cerebral disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Change in seizure presentation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Drooling
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dysgeusia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Dysstasia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Epilepsy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Focal dyscognitive seizures
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Hemiplegia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Hyposmia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Language disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Loss of consciousness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Neuralgia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Neuropathy peripheral
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Postictal headache
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Postural tremor
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Radial nerve palsy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Seizure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
2.4%
16/679 • Number of events 19 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Seizure cluster
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Sleep deficit
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Slow response to stimuli
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Speech disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Status epilepticus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Tonic convulsion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Visual field defect
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Vocal cord paralysis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Blepharitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Borderline glaucoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Conjunctival hyperaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Conjunctivitis allergic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 5 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Corneal erosion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Diabetic retinopathy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Episcleritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Excessive eye blinking
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Eye discharge
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Eye pruritus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Eyelid myoclonus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Foreign body sensation in eyes
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Keratitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Ocular hyperaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Psychogenic visual disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Punctate keratitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Swelling of eyelid
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Visual acuity reduced
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Eye disorders
Xerophthalmia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Deafness neurosensory
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Ear pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Ear pruritus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Hypoacusis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Motion sickness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Sudden hearing loss
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Ear and labyrinth disorders
Vertigo positional
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 7 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Breath odour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Chronic gastritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Dysphagia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Enterocolitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Faecaloma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Faeces soft
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Food poisoning
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingival hypertrophy
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Glossitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Ileus paralytic
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Irritable bowel syndrome
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Lip ulceration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Lumbar hernia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Noninfective gingivitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Oesophagitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Oral contusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Peptic ulcer
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Salivary gland mucocoele
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Calculus urinary
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Ketonuria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Renal cyst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Renal and urinary disorders
Urinary retention
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Androgenetic alopecia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Anhidrosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Fracture blisters
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Miliaria
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Onychalgia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Candida infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Pruritus generalised
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin discolouration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin fissures
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Product Issues
Device breakage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Product Issues
Product blister packaging issue
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Muscle tightness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Osteoporosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Posture abnormal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Musculoskeletal and connective tissue disorders
Tendonitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Endocrine disorders
Autoimmune thyroiditis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Endocrine disorders
Hypothyroidism
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyperammonaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypermagnesaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.74%
5/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 6 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Metabolism and nutrition disorders
Obesity
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Angular cheilitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Bartholin's abscess
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Carbuncle
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Cellulitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Chronic sinusitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Conjunctivitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.6%
11/679 • Number of events 12 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Cystitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Dermatophytosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Dermatophytosis of nail
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Ear infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Eczema impetiginous
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Enteritis infectious
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Eye infection bacterial
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Folliculitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Fungal infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Fungal skin infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Gingival abscess
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Helicobacter infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Herpes dermatitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Hordeolum
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Infected dermal cyst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Kidney infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Lung infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Mumps
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Oral candidiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Paronychia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pericoronitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Peritonsillar abscess
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Pyoderma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Tinea manuum
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Vaginal infection
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Varicella
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Infections and infestations
Vulvovaginitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Hyperaemia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Orthostatic hypotension
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Peripheral coldness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Vascular disorders
Phlebitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Surgical and medical procedures
Tooth extraction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Surgical and medical procedures
Wisdom teeth removal
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatobiliary neoplasm
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Social circumstances
Hearing aid user
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Chest pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Chills
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Decreased activity
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Feeling hot
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Generalised oedema
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Oedema peripheral
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Peripheral swelling
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
General disorders
Thirst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Bipolar disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Bruxism
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Confusional state
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Conversion disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Delusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Depressive symptom
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Dissociative disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Enuresis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Hallucination
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Impulsive behaviour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Major depression
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mania
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mental disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Middle insomnia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Mixed anxiety and depressive disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Neurosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Nightmare
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Panic disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Paranoia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Persecutory delusion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Persistent depressive disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Psychogenic seizure
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.59%
4/679 • Number of events 4 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Somatic symptom disorder
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Stress
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Suicidal behaviour
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Amenorrhoea
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Breast tenderness
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Genital haemorrhage
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Menopausal symptoms
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Menstruation delayed
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Oligomenorrhoea
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Ovarian cyst
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Scrotal inflammation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Sexual dysfunction
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Vaginal discharge
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Reproductive system and breast disorders
Laryngeal discomfort
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Hyperventilation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.44%
3/679 • Number of events 3 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Sputum increased
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.29%
2/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Hepatic mass
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Gingivitis
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
1.1%
2/176 • Number of events 2 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/679 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Gastrointestinal disorders
Haematochezia
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Nervous system disorders
Burning sensation
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.15%
1/679 • Number of events 1 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
Psychiatric disorders
Irritability
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/176 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/175 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
0.00%
0/180 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.
9.0%
61/679 • Number of events 72 • From the date of first dose up to 30 days after the last dose of study drug (up to Week 79)
Planned safety analysis of Extension Phase included treatment emergent AEs on/after first day of perampanel treatment in entire study. Analysis set for Extension Phase included 679 participants: 596 had perampanel in Core Phase \& at least one dose of perampanel in Extension Phase, 83 had perampanel in Core Phase only. Participants received varying doses in Extension Phase depending on tolerance but as target dose was defined as 12 mg/day for all participants, AEs were summarized as a single arm.

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  • Principal investigator is a sponsor employee
  • Publication restrictions are in place