Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures (NCT NCT00735397)

NCT ID: NCT00735397

Last Updated: 2016-03-14

Results Overview

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1218 participants

Primary outcome timeframe

From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.

Results posted on

2016-03-14

Participant Flow

This was an open-label Extension (OLE) study for participants who completed one of the following double-blind (DB), placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305(NCT00699582), and E2007-G000-306 (NCT00700310).

From a total of 1218 participants who provided informed consent, 2 participants were lost to follow-up and did not have any postbaseline safety data after the first OLE dose.

Participant milestones

Participant milestones
Measure
Perampanel
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Study
STARTED
1218
Overall Study
COMPLETED
35
Overall Study
NOT COMPLETED
1183

Reasons for withdrawal

Reasons for withdrawal
Measure
Perampanel
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Overall Study
Adverse Event
194
Overall Study
Lost to Follow-up
33
Overall Study
Participant choice
252
Overall Study
Inadequate therapeutic effect
202
Overall Study
Administrative/Other
502

Baseline Characteristics

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Perampanel
n=1218 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Age, Continuous
33 years
n=5 Participants
Sex: Female, Male
Female
607 Participants
n=5 Participants
Sex: Female, Male
Male
611 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.

Population: The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Outcome measures

Outcome measures
Measure
Perampanel
n=1216 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Complex Partial Plus Secondarily Generalized Seizures
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Secondarily Generalized Seizures
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
Treatment-emergent non serious AEs
1018 participants
Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
Treatment-emergent SAEs
288 participants

SECONDARY outcome

Timeframe: Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)

Population: Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.

Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.

Outcome measures

Outcome measures
Measure
Perampanel
n=1217 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Complex Partial Plus Secondarily Generalized Seizures
n=1126 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Secondarily Generalized Seizures
n=510 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 1-13
-29.14 Percent change
Interval -100.0 to 737.1
-32.42 Percent change
Interval -100.0 to 14858.2
-54.95 Percent change
Interval -100.0 to 530.8
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 14-26, n = 1159, 1073, 482
-38.54 Percent change
Interval -100.0 to 866.6
-43.19 Percent change
Interval -100.0 to 12965.9
-65.69 Percent change
Interval -100.0 to 628.6
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 144-156, n = 517, 478, 231
-61.45 Percent change
Interval -100.0 to 570.2
-67.95 Percent change
Interval -100.0 to 562.6
-100.00 Percent change
Interval -100.0 to 936.3
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Wekks 27-39, n = 1088, 1011, 458
-42.81 Percent change
Interval -100.0 to 780.6
-46.22 Percent change
Interval -100.0 to 14092.3
-77.47 Percent change
Interval -100.0 to 756.0
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 40-52, n = 969, 903, 416
-46.22 Percent change
Interval -100.0 to 685.7
-49.39 Percent change
Interval -100.0 to 898.1
-81.15 Percent change
Interval -100.0 to 898.1
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 53-65, n = 882, 819, 381
-49.34 Percent change
Interval -100.0 to 526.4
-54.95 Percent change
Interval -100.0 to 1071.4
-80.69 Percent change
Interval -100.0 to 891.2
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 66-78, n = 822, 762, 357
-51.65 Percent change
Interval -100.0 to 861.5
-56.25 Percent change
Interval -100.0 to 620.9
-79.98 Percent change
Interval -100.0 to 891.2
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 79-91, n = 762, 703, 329
-53.06 Percent change
Interval -100.0 to 697.5
-55.38 Percent change
Interval -100.0 to 1000.6
-90.68 Percent change
Interval -100.0 to 1071.4
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 92-104, n = 720, 664, 313
-56.59 Percent change
Interval -100.0 to 660.9
-62.11 Percent change
Interval -100.0 to 717.2
-90.33 Percent change
Interval -100.0 to 891.2
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 105-117, n = 676, 624, 295
-59.07 Percent change
Interval -100.0 to 627.9
-63.62 Percent change
Interval -100.0 to 627.9
-84.98 Percent change
Interval -100.0 to 1071.4
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 118-130, n = 642, 590, 279
-60.89 Percent change
Interval -100.0 to 540.0
-66.75 Percent change
Interval -100.0 to 821.1
-100.00 Percent change
Interval -100.0 to 1281.0
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 131-143, n = 583, 535, 258
-60.67 Percent change
Interval -100.0 to 716.0
-65.46 Percent change
Interval -100.0 to 717.5
-99.70 Percent change
Interval -100.0 to 801.1
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 157-169, n = 429, 396, 187
-65.46 Percent change
Interval -100.0 to 418.3
-72.21 Percent change
Interval -100.0 to 264.4
-100.00 Percent change
Interval -100.0 to 350.0
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 170-182, n = 323, 297, 137
-64.29 Percent change
Interval -100.0 to 367.4
-76.37 Percent change
Interval -100.0 to 268.2
-100.00 Percent change
Interval -100.0 to 269.2
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 183-195, n = 210, 193, 89
-66.63 Percent change
Interval -100.0 to 698.7
-74.78 Percent change
Interval -100.0 to 867.1
-100.00 Percent change
Interval -100.0 to 320.3
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 196-208, n = 119, 111, 47
-73.30 Percent change
Interval -100.0 to 671.8
-80.77 Percent change
Interval -100.0 to 671.8
-100.00 Percent change
Interval -100.0 to 147.3
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 209-221, n = 59, 57, 22
-72.47 Percent change
Interval -100.0 to 226.4
-80.69 Percent change
Interval -100.0 to 211.4
-100.00 Percent change
Interval -100.0 to 55.8
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 222-234, n = 37, 36, 11
-81.36 Percent change
Interval -100.0 to 175.3
-89.02 Percent change
Interval -100.0 to 75.3
-99.11 Percent change
Interval -100.0 to 75.3
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 235-247, n = 14, 13, 2
-78.10 Percent change
Interval -100.0 to 200.4
-100.0 Percent change
Interval -100.0 to 71.4
-100.00 Percent change
Interval -100.0 to -100.0
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
Weeks 248-260, n = 5, 5, 1
-97.16 Percent change
Interval -100.0 to 250.4
-98.39 Percent change
Interval -100.0 to -90.0
-98.39 Percent change
Interval -98.39 to -98.39

SECONDARY outcome

Timeframe: Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)

Population: Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.

Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.

Outcome measures

Outcome measures
Measure
Perampanel
n=1217 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Complex Partial Plus Secondarily Generalized Seizures
n=1126 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Secondarily Generalized Seizures
n=510 Participants
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 40-52, n = 969, 903, 416
45.6 Percent responders
49.4 Percent responders
67.8 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 183-195, n = 210, 193, 89
62.9 Percent responders
68.4 Percent responders
80.9 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 1-13
30.8 Percent responders
34.8 Percent responders
54.5 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 14-26, n = 1159, 1073, 482
40.9 Percent responders
43.4 Percent responders
58.7 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 27-39, n = 1088, 1011, 458
44.2 Percent responders
47.3 Percent responders
63.3 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 53-65, n = 882, 819, 381
49.5 Percent responders
53.2 Percent responders
65.6 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 66-78, n = 822, 762, 357
51.5 Percent responders
54.9 Percent responders
66.1 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 79-91, n = 762, 703, 329
52.9 Percent responders
55.6 Percent responders
66.0 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 92-104, n = 720, 664, 313
57.2 Percent responders
58.6 Percent responders
69.3 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 105-117, n = 676, 624, 295
57.1 Percent responders
59.5 Percent responders
68.1 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 118-130, n = 642, 590, 279
58.9 Percent responders
61.9 Percent responders
71.3 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 131-143, n = 583, 535, 258
59.3 Percent responders
61.5 Percent responders
71.3 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 144-156, n = 517, 478, 231
60.9 Percent responders
62.6 Percent responders
74.0 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 157-169, n = 429, 396, 187
63.2 Percent responders
65.7 Percent responders
76.5 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 170-182, n = 323, 297, 137
60.1 Percent responders
64.3 Percent responders
78.8 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 196-208, n = 119, 111, 47
64.7 Percent responders
71.2 Percent responders
85.1 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 209-221, n = 59, 57, 22
67.8 Percent responders
73.7 Percent responders
77.3 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 222-234, n = 37, 36, 11
73.0 Percent responders
75.0 Percent responders
72.7 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 235-247, n = 14, 13, 2
64.3 Percent responders
69.2 Percent responders
100.0 Percent responders
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
Weeks 248-260, n = 5, 5, 1
80.0 Percent responders
100.0 Percent responders
100.0 Percent responders

Adverse Events

Perampanel

Serious events: 288 serious events
Other events: 1018 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Perampanel
n=1216 participants at risk
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Vascular disorders
Hypertension
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Vascular disorders
Aortic aneurysm
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Vascular disorders
Deep vein thrombosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Vascular disorders
Hypotension
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Surgical and medical procedures
Abortion induced
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Surgical and medical procedures
Medical device removal
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Gait disturbance
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Pain
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Cyst
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Death
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Drug ineffective
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Fatigue
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
General physical health deterioration
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Hyperthermia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Non-cardiac chest pain
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Pyrexia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Sudden death
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Aggression
1.2%
14/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Psychotic disorder
0.66%
8/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Suicidal ideation
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Affective disorder
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Depression
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Acute psychosis
0.33%
4/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Suicide attempt
0.33%
4/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Disorientation
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Paranoia
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Abnormal behaviour
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Agitation
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Adjustment disorder
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Anger
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Catanoia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Confusional state
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Delirium
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Delusion
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Delusion of grandeur
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Epileptic psychosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Hallucination,auditory
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Homicidal ideation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Insomnia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Irritability
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Major depression
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Mental disorder due to a general medical condition
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Mental status changes
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Mood altered
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Negativism
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Obsessive thoughts
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Personlaity change due to a general medical condition
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Postictal psychosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Dysfuntional uterine bleeding
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Bartholinitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Breast enlargement
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Menstrual disorder
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Ovarian cyst
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Ovarian mass
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Ovarian rupture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Polycystic ovaries
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Uterine cyst
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Uterine haemorrhage
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Reproductive system and breast disorders
Uterine polyp
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Head injury
0.99%
12/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Ankle fracture
0.58%
7/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Fall
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Road traffic accident
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Toxicity to various agents
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Contusion
0.33%
4/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Facial bones fracture
0.33%
4/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Craniocerebral injury
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Foot fracture
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Accidental overdose
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Brain contusion
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Clavicle fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Extradural haematoma
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Fibula fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Hand fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Humerus fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Jaw fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Laceration
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Lower limb fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Rib fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Subdural haematoma
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Tibia fracture
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Abdominal injury
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Animal bite
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Burns second degree
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Burns third degree
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Cartilage injury
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Cervical vertebral fracture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Concussion
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Epidural haemorrhage
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Excoriation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Forearm fracture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Hip fracture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Intentional overdose
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Joint dislocation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Limb injury
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Limb traumatic amputation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Muscle strain
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Neck injury
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Post concussion syndrome
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Procedural intestinal perforation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Radius fracture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Skin laceration
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Skull fracture
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Skull fractured base
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Subcutaneous haematoma
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Subdural haemorrhage
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Traumatic iritis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Wound
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations
Clostridium test positive
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations
Heart rate irregular
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations
Weight decreased
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Angina pectoris
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Atrial fibrillation
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Bradycardia
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Acute coronary syndrome
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Angina unstable
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Atrial flutter
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Atrioventricular dissociation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Cardiac failure
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Cardiovascular insufficiency
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Coronary artery stenosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Mitral valve incompetence
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Myocardial infarction
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Cardiac disorders
Sick sinas syndrome
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Congenital, familial and genetic disorders
Skull malformation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Blood and lymphatic system disorders
Anaemia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Convulsion
3.5%
43/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Status epilepticus
1.3%
16/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Epilepsy
1.2%
15/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Dizziness
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Grand mal convulsion
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Seizure cluster
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Ataxia
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Partial seizures
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Partial seizures with secondary generalisation
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Cerebral haemorrhage
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Cerebrovascular accident
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Drug withdrawal convulsions
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Dysarthria
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Hemiparesis
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Hypoasthesia
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Somnolence
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Syncope
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Carotid artery dissection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Carpal tunnel syndrome
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Central nervous system lesion
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Cerebral infarction
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Cognitive disorder
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Coma
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Complex partial seizures
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Dementia Alzheimer's type
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Haemorrhage intracranial
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Headache
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Incoherent
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Memory impairment
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Multifocal motor nueropathy
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Peripheral sensorimotor neuropathy
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Postictal paralysis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Psychomotor hyperactivity
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Simple partial seizures
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Speech disorder
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Spinal cord compression
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Subarachnoid haemorrhage
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Temporal lobe epilepsy
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Transient ischaemic attack
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Tremor
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Vertebral artery dissection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Stupor
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Eye disorders
Conjunctivitis allergic
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Eye disorders
Iritis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Eye disorders
Visual impairment
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Ear and labyrinth disorders
Vertigo
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Ear and labyrinth disorders
Conductive deafness
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Gastritis
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Nausea
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Colitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Colitis ischaemic
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Colitis microscopic
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Duodenal ulcer
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Duodenitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Enterocolitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Gastroesophageal reflux disease
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Ileus
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Inguinal hernia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Pancreatitis acute
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Small intestine obstruction
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Vomiting
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Renal and urinary disorders
Nephrolithiasis
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Renal and urinary disorders
Urinary retention
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Hepatobiliary disorders
Cholelithiasis
0.33%
4/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Hepatobiliary disorders
Cholecystitis
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
osteoarthritis
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Back pain
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Bursitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Periarthritis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Pseudarthrosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Scoliosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Endocrine disorders
Goitre
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Hyponatraemia
0.25%
3/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Dehydration
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Hypernatraemia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Hypochloraemia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Metabolism and nutrition disorders
Hypovolaemia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Pneumonia
1.1%
13/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Urinary tract infection
0.49%
6/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Appendicitis
0.41%
5/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Device related infection
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Postoperative wound infection
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Tooth abscess
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Wound infection staphylococcal
0.16%
2/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Abscess limb
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Appendicitis perforated
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Bacterial disease carrier
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Bronchitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Cellulitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Influenza
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Klebsiella infection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Meningitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Oral infection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Pharyngitis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Post procedural pneumonia
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Pyelonephritis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Renal cyst infection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Respiratory tract infection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Sepsis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Septic shock
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Tuberculosis
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Typhoid fever
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Wound infection
0.08%
1/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Other adverse events

Other adverse events
Measure
Perampanel
n=1216 participants at risk
Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
Injury, poisoning and procedural complications
Fall
9.5%
116/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Injury, poisoning and procedural complications
Laceration
5.5%
67/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Investigations
Weight increased
13.2%
161/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Ataxia
6.9%
84/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Balance disorder
6.1%
74/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Convulsion
6.4%
78/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Dizziness
48.6%
591/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Dysarthria
5.0%
61/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Headache
20.2%
246/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Nervous system disorders
Somnolence
21.9%
266/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Eye disorders
Diplopia
5.3%
64/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Fatigue
15.0%
182/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Irritability
5.7%
69/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Gait disturbacne
6.6%
80/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
General disorders
Pyrexia
6.5%
79/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Ear and labyrinth disorders
Vertigo
6.4%
78/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Anxiety
6.5%
79/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Depression
6.7%
82/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Insomnia
7.1%
86/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Psychiatric disorders
Irritability
10.3%
125/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Diarrhoea
6.9%
84/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Nausea
9.5%
115/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Gastrointestinal disorders
Vomiting
7.8%
95/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Influenza
5.8%
70/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Nasopharyngitis
11.7%
142/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Infections and infestations
Upper respiratory tract infection
8.8%
107/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Musculoskeletal and connective tissue disorders
Back pain
7.1%
86/1216 • From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years
In this study, treatment emergent AE (defined as an AE/SAE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

Additional Information

Eisai Call Center

Eisai Inc.

Phone: 888-422-4743

Results disclosure agreements

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

Restriction type: OTHER