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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01618695
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : June 5, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Partial-onset Seizures
Interventions Drug: Perampanel
Drug: Placebo
Enrollment 940
Recruitment Details Participants took part in the study at 119 investigative sites in Australia, China, Korea, Japan, Malaysia, Taiwan, and Thailand. A total of 940 participants were enrolled and screened, of which 230 were screen failures, 710 were randomized in Core Phase of study.
Pre-assignment Details This study included a Core Phase and an Extension Phase. This result summary includes data only for the Core Phase of the study at the primary completion date (15 September 2014). Extension Phase results will be provided upon study completion.
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks). Participants received perampanel 2 milligrams (mg) tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Period Title: Overall Study
Started 177 176 177 180
Treated (Safety Analysis Set) 176 176 175 180
Completed 152 156 147 144
Not Completed 25 20 30 36
Reason Not Completed
Adverse Event             4             5             15             20
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             16             11             9             13
Pregnancy             2             0             0             0
Lack of Efficacy             1             2             1             1
Other than specified             1             2             2             2
Not treated             1             0             2             0
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg Total
Hide Arm/Group Description Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks). Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Total of all reporting groups
Overall Number of Baseline Participants 176 176 175 180 707
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one post-dose safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 176 participants 175 participants 180 participants 707 participants
34.5  (13.21) 33.1  (13.18) 33.6  (14.11) 32.3  (12.30) 33.4  (13.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 175 participants 180 participants 707 participants
Female
90
  51.1%
94
  53.4%
84
  48.0%
93
  51.7%
361
  51.1%
Male
86
  48.9%
82
  46.6%
91
  52.0%
87
  48.3%
346
  48.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 175 participants 180 participants 707 participants
Hispanic or Latino
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.6%
2
   0.3%
Not Hispanic or Latino
176
 100.0%
175
  99.4%
175
 100.0%
179
  99.4%
705
  99.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 175 participants 180 participants 707 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
169
  96.0%
168
  95.5%
159
  90.9%
171
  95.0%
667
  94.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
1
   0.1%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
7
   4.0%
7
   4.0%
14
   8.0%
7
   3.9%
35
   5.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.6%
2
   1.1%
4
   0.6%
1.Primary Outcome
Title Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Hide Description Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.
Time Frame Baseline, Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description:
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Overall Number of Participants Analyzed 175 174 175 180
Median (Full Range)
Unit of Measure: percent change
-10.76
(-90.4 to 400.0)
-17.32
(-97.1 to 473.4)
-28.95
(-100.0 to 809.4)
-38.03
(-100.0 to 456.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2330
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -5.09
Confidence Interval (2-Sided) 95%
-14.112 to 4.519
Estimation Comments Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 8 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -16.45
Confidence Interval (2-Sided) 95%
-25.683 to -7.251
Estimation Comments Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 12 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -24.95
Confidence Interval (2-Sided) 95%
-33.878 to -16.235
Estimation Comments Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
2.Secondary Outcome
Title Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Hide Description Responder rate was percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (<) 50%, then the participants are considered as non-responders.
Time Frame Baseline, Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description:
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Overall Number of Participants Analyzed 175 174 175 180
Measure Type: Number
Unit of Measure: percentage of participants
19.4 23.0 36.0 43.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3954
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 8 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 12 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Hide Description Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
Time Frame Baseline, Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description:
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Overall Number of Participants Analyzed 158 151 157 167
Median (Full Range)
Unit of Measure: percent change
-11.70
(-88.6 to 400.0)
-19.08
(-100.0 to 410.0)
-33.68
(-100.0 to 1103.4)
-41.80
(-100.0 to 456.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 4 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0552
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -8.27
Confidence Interval (2-Sided) 95%
-18.067 to 1.671
Estimation Comments Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 8 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -21.21
Confidence Interval (2-Sided) 95%
-30.941 to -11.368
Estimation Comments Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Perampanel 12 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -28.65
Confidence Interval (2-Sided) 95%
-37.698 to -19.794
Estimation Comments Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.
4.Secondary Outcome
Title Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Hide Description The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events, and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement. Higher score indicated worsening.
Time Frame Baseline, Week 19
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one postdose seizure frequency data.
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description:
Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks).
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
Overall Number of Participants Analyzed 175 174 175 180
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
3
   1.7%
5
   2.9%
11
   6.3%
9
   5.0%
Much improved
31
  17.7%
39
  22.4%
41
  23.4%
54
  30.0%
Minimally improved
54
  30.9%
45
  25.9%
53
  30.3%
40
  22.2%
No change
67
  38.3%
56
  32.2%
37
  21.1%
37
  20.6%
Minimally worse
3
   1.7%
10
   5.7%
5
   2.9%
4
   2.2%
Much worse
1
   0.6%
0
   0.0%
0
   0.0%
1
   0.6%
Very much worse
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
Time Frame From the date of first dose up to 30 days after the last dose of study drug (up to Week 23)
Adverse Event Reporting Description Safety Analysis Set included all participants who signed informed consent, were randomized, received at least one dose of study medication, and have at least one post-dose safety assessment.
 
Arm/Group Title Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Hide Arm/Group Description Participants received perampanel-matched placebo tablets (6 tablets), orally, once daily before bedtime from Week 0 up to Week 18 (up to 19 weeks). Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 4 mg orally once daily from Week 1 up to Week 5 (titration period), followed by perampanel 4 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 8 mg (weekly increment of 2 mg from Week 1 up to Week 3) orally once daily for up to Week 5 (titration period), followed by perampanel 8 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks. Participants received perampanel 2 mg tablet, orally once daily before bedtime in Week 0 and then titrated up to maximum dose of 12 mg (weekly increment of 2 mg from Week 1 up to Week 5) orally once daily for up to Week 5 (titration period), followed by perampanel 12 mg, orally once daily from Week 6 up to Week 18 (maintenance period). Total duration of titration and maintenance period is 19 weeks.
All-Cause Mortality
Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/176 (0.57%)   0/176 (0.00%)   1/175 (0.57%)   0/180 (0.00%) 
Hide Serious Adverse Events
Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/176 (5.68%)   6/176 (3.41%)   7/175 (4.00%)   12/180 (6.67%) 
Gastrointestinal disorders         
Haemorrhoids  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Gastrointestinal haemorrhage  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
General disorders         
Death  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Sudden cardiac death  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Infections and infestations         
Anal abscess  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Cellulitis  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Pneumonia  1  2/176 (1.14%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Pyelonephritis acute  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Renal abscess  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Injury, poisoning and procedural complications         
Brain contusion  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Burns second degree  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Facial bones fracture  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Road traffic accident  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Contusion  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Nervous system disorders         
Epilepsy  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Status epilepticus  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Complex partial seizures  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Convulsion  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Haemorrhage intracranial  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Partial seizures with secondary generalisation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Grand mal convulsion  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Psychiatric disorders         
Aggression  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Suicide attempt  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Acute psychosis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Conversion disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Self-injurious ideation  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Reproductive system and breast disorders         
Adenomyosis  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Skin and subcutaneous tissue disorders         
Excessive granulation tissue  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Surgical and medical procedures         
Abortion induced  1  2/176 (1.14%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
1
Term from vocabulary, 13.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Perampanel 4 mg Perampanel 8 mg Perampanel 12 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   114/176 (64.77%)   119/176 (67.61%)   127/175 (72.57%)   155/180 (86.11%) 
Blood and lymphatic system disorders         
Anaemia  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Lymphadenitis  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Eosinophilia  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Iron deficiency anaemia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Leukopenia  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Neutropenia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Cardiac disorders         
Angina pectoris  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Atrial fibrillation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  1/176 (0.57%)  3/176 (1.70%)  5/175 (2.86%)  4/180 (2.22%) 
Cerumen impaction  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Tinnitus  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Eye disorders         
Vision blurred  1  0/176 (0.00%)  2/176 (1.14%)  2/175 (1.14%)  3/180 (1.67%) 
Asthenopia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Conjunctivitis  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  2/180 (1.11%) 
Diplopia  1  1/176 (0.57%)  0/176 (0.00%)  2/175 (1.14%)  1/180 (0.56%) 
Eyelid oedema  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Visual impairment  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Cataract  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Chalazion  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Conjunctival haemorrhage  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dry eye  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Dysmetropsia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Glaucoma  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Keratoconjunctivitis sicca  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Normal tension glaucoma  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Retinal disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Vitreous floaters  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Eye pain  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Lacrimation increased  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Gastrointestinal disorders         
Nausea  1  6/176 (3.41%)  4/176 (2.27%)  4/175 (2.29%)  10/180 (5.56%) 
Diarrhoea  1  6/176 (3.41%)  3/176 (1.70%)  4/175 (2.29%)  6/180 (3.33%) 
Stomatitis  1  1/176 (0.57%)  2/176 (1.14%)  5/175 (2.86%)  3/180 (1.67%) 
Constipation  1  1/176 (0.57%)  2/176 (1.14%)  5/175 (2.86%)  1/180 (0.56%) 
Vomiting  1  7/176 (3.98%)  1/176 (0.57%)  1/175 (0.57%)  3/180 (1.67%) 
Abdominal discomfort  1  3/176 (1.70%)  1/176 (0.57%)  1/175 (0.57%)  2/180 (1.11%) 
Abdominal pain  1  1/176 (0.57%)  2/176 (1.14%)  0/175 (0.00%)  2/180 (1.11%) 
Dyspepsia  1  0/176 (0.00%)  1/176 (0.57%)  3/175 (1.71%)  0/180 (0.00%) 
Gastritis  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Toothache  1  1/176 (0.57%)  1/176 (0.57%)  2/175 (1.14%)  0/180 (0.00%) 
Abdominal pain lower  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Cheilitis  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Dental caries  1  1/176 (0.57%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Gingivitis  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Abdominal pain upper  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Aphthous stomatitis  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Colonic polyp  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Crohn's disease  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Gingival bleeding  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Gingival hyperplasia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Gingival pain  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Gingival ulceration  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Haemorrhoids  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Oral disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Oral pain  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Periodontal disease  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Reflux oesophagitis  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Salivary hypersecretion  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dry mouth  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Enteritis  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Epigastric discomfort  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Gastritis atrophic  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Lip dry  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Periodontitis  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
General disorders         
Irritability  1  1/176 (0.57%)  8/176 (4.55%)  10/175 (5.71%)  9/180 (5.00%) 
Fatigue  1  5/176 (2.84%)  4/176 (2.27%)  6/175 (3.43%)  9/180 (5.00%) 
Gait disturbance  1  3/176 (1.70%)  2/176 (1.14%)  4/175 (2.29%)  9/180 (5.00%) 
Pyrexia  1  3/176 (1.70%)  2/176 (1.14%)  4/175 (2.29%)  4/180 (2.22%) 
Asthenia  1  1/176 (0.57%)  0/176 (0.00%)  2/175 (1.14%)  2/180 (1.11%) 
Malaise  1  0/176 (0.00%)  1/176 (0.57%)  2/175 (1.14%)  0/180 (0.00%) 
Feeling abnormal  1  0/176 (0.00%)  1/176 (0.57%)  1/175 (0.57%)  0/180 (0.00%) 
Device breakage  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Face oedema  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Foreign body reaction  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Influenza like illness  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Oedema  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Chest discomfort  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Pain  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Cholecystitis  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Immune system disorders         
Allergy to arthropod sting  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Seasonal allergy  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  26/176 (14.77%)  23/176 (13.07%)  24/175 (13.71%)  23/180 (12.78%) 
Upper respiratory tract infection  1  8/176 (4.55%)  8/176 (4.55%)  14/175 (8.00%)  11/180 (6.11%) 
Pharyngitis  1  3/176 (1.70%)  1/176 (0.57%)  4/175 (2.29%)  2/180 (1.11%) 
Influenza  1  2/176 (1.14%)  3/176 (1.70%)  1/175 (0.57%)  2/180 (1.11%) 
Gastroenteritis  1  1/176 (0.57%)  2/176 (1.14%)  2/175 (1.14%)  1/180 (0.56%) 
Tinea pedis  1  0/176 (0.00%)  1/176 (0.57%)  1/175 (0.57%)  1/180 (0.56%) 
Bronchitis  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Gastroenteritis viral  1  0/176 (0.00%)  1/176 (0.57%)  1/175 (0.57%)  0/180 (0.00%) 
Oral herpes  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Rhinitis  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Bacterial infection  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Gastroenteritis bacterial  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Herpes zoster  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Impetigo  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Otitis externa  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Otitis media  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Pneumonia  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Purulence  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Respiratory tract infection  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Sinusitis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Syphilis  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Tonsillitis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Urinary tract infection  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Viral infection  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Wound infection  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Eczema infected  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Onychomycosis  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  4/176 (2.27%)  5/176 (2.84%)  6/175 (3.43%)  5/180 (2.78%) 
Joint sprain  1  0/176 (0.00%)  3/176 (1.70%)  2/175 (1.14%)  3/180 (1.67%) 
Excoriation  1  3/176 (1.70%)  1/176 (0.57%)  1/175 (0.57%)  2/180 (1.11%) 
Foot fracture  1  1/176 (0.57%)  1/176 (0.57%)  1/175 (0.57%)  1/180 (0.56%) 
Skin laceration  1  3/176 (1.70%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Thermal burn  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Wound  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  2/180 (1.11%) 
Animal bite  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Fall  1  2/176 (1.14%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Head injury  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Limb injury  1  0/176 (0.00%)  1/176 (0.57%)  1/175 (0.57%)  0/180 (0.00%) 
Lip injury  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Rib fracture  1  1/176 (0.57%)  1/176 (0.57%)  1/175 (0.57%)  0/180 (0.00%) 
Ankle fracture  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Arthropod sting  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Burns second degree  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Heat stroke  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Joint dislocation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Ligament rupture  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Multiple injuries  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Periorbital haematoma  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Radius fracture  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Road traffic accident  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Stab wound  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Sunburn  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Tibia fracture  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Tooth fracture  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Tooth injury  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Wrist fracture  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Forearm fracture  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Scratch  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Investigations         
Weight increased  1  1/176 (0.57%)  7/176 (3.98%)  6/175 (3.43%)  6/180 (3.33%) 
Blood creatine phosphokinase increased  1  0/176 (0.00%)  1/176 (0.57%)  2/175 (1.14%)  5/180 (2.78%) 
Electrocardiogram QT prolonged  1  1/176 (0.57%)  2/176 (1.14%)  0/175 (0.00%)  4/180 (2.22%) 
Blood phosphorus decreased  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Protein urine present  1  2/176 (1.14%)  0/176 (0.00%)  2/175 (1.14%)  1/180 (0.56%) 
Weight decreased  1  1/176 (0.57%)  0/176 (0.00%)  2/175 (1.14%)  1/180 (0.56%) 
Blood cholesterol increased  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Blood uric acid increased  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Gamma-glutamyltransferase increased  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
White blood cell count decreased  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Alanine aminotransferase increased  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Aspartate aminotransferase increased  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Blood parathyroid hormone abnormal  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Blood sodium decreased  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Blood triglycerides abnormal  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Eosinophil count increased  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Monocyte count increased  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Neutrophil count decreased  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Platelet count decreased  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Red blood cells urine  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Urine ketone body present  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Vitamin D decreased  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Blood glucose increased  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Blood triglycerides increased  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Blood urine present  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  3/176 (1.70%)  1/176 (0.57%)  5/175 (2.86%)  3/180 (1.67%) 
Hyponatraemia  1  0/176 (0.00%)  1/176 (0.57%)  2/175 (1.14%)  2/180 (1.11%) 
Increased appetite  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  3/180 (1.67%) 
Dyslipidaemia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Hyperlipidaemia  1  0/176 (0.00%)  0/176 (0.00%)  3/175 (1.71%)  0/180 (0.00%) 
Diabetes mellitus  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Hypochloraemia  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Dehydration  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Hypertriglyceridaemia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Hypokalaemia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Weight fluctuation  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Appetite disorder  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Hyperglycaemia  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscular weakness  1  0/176 (0.00%)  0/176 (0.00%)  4/175 (2.29%)  2/180 (1.11%) 
Back pain  1  1/176 (0.57%)  1/176 (0.57%)  2/175 (1.14%)  2/180 (1.11%) 
Myalgia  1  2/176 (1.14%)  2/176 (1.14%)  0/175 (0.00%)  1/180 (0.56%) 
Arthralgia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Musculoskeletal pain  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Musculoskeletal stiffness  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  2/180 (1.11%) 
Pain in extremity  1  2/176 (1.14%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Monarthritis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Muscle spasms  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Muscle twitching  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Musculoskeletal chest pain  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Myokymia  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Tenosynovitis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Flank pain  1  2/176 (1.14%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Neck pain  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Osteoarthritis  1  2/176 (1.14%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lipoma  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Nervous system disorders         
Dizziness  1  10/176 (5.68%)  40/176 (22.73%)  50/175 (28.57%)  76/180 (42.22%) 
Somnolence  1  23/176 (13.07%)  28/176 (15.91%)  31/175 (17.71%)  32/180 (17.78%) 
Headache  1  13/176 (7.39%)  12/176 (6.82%)  13/175 (7.43%)  10/180 (5.56%) 
Ataxia  1  0/176 (0.00%)  2/176 (1.14%)  1/175 (0.57%)  7/180 (3.89%) 
Balance disorder  1  0/176 (0.00%)  4/176 (2.27%)  1/175 (0.57%)  4/180 (2.22%) 
Dysarthria  1  1/176 (0.57%)  0/176 (0.00%)  3/175 (1.71%)  4/180 (2.22%) 
Hypoaesthesia  1  1/176 (0.57%)  3/176 (1.70%)  1/175 (0.57%)  2/180 (1.11%) 
Tremor  1  1/176 (0.57%)  2/176 (1.14%)  0/175 (0.00%)  3/180 (1.67%) 
Convulsion  1  1/176 (0.57%)  2/176 (1.14%)  0/175 (0.00%)  2/180 (1.11%) 
Memory impairment  1  0/176 (0.00%)  1/176 (0.57%)  1/175 (0.57%)  2/180 (1.11%) 
Nystagmus  1  0/176 (0.00%)  2/176 (1.14%)  1/175 (0.57%)  1/180 (0.56%) 
Amnesia  1  0/176 (0.00%)  2/176 (1.14%)  1/175 (0.57%)  0/180 (0.00%) 
Complex partial seizures  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Dementia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Lethargy  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  0/180 (0.00%) 
Paraesthesia  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Aphasia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Clumsiness  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Cranial nerve disorder  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Dizziness postural  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Dysaesthesia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Dyskinesia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Dystonia  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Head discomfort  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Hypersomnia  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Migraine  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Myoclonus  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Nerve root compression  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Psychomotor hyperactivity  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Sensory disturbance  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Anaesthesia  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Dyslalia  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Grand mal convulsion  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Partial seizures with secondary generalisation  1  3/176 (1.70%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Syncope  1  2/176 (1.14%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Tongue biting  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Pregnancy  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Psychiatric disorders         
Aggression  1  0/176 (0.00%)  4/176 (2.27%)  5/175 (2.86%)  4/180 (2.22%) 
Suicidal ideation  1  1/176 (0.57%)  3/176 (1.70%)  7/175 (4.00%)  2/180 (1.11%) 
Anxiety  1  0/176 (0.00%)  1/176 (0.57%)  6/175 (3.43%)  1/180 (0.56%) 
Insomnia  1  7/176 (3.98%)  3/176 (1.70%)  2/175 (1.14%)  3/180 (1.67%) 
Mood swings  1  1/176 (0.57%)  3/176 (1.70%)  2/175 (1.14%)  0/180 (0.00%) 
Anger  1  1/176 (0.57%)  0/176 (0.00%)  1/175 (0.57%)  3/180 (1.67%) 
Depression  1  0/176 (0.00%)  0/176 (0.00%)  2/175 (1.14%)  2/180 (1.11%) 
Affect lability  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Depressed mood  1  1/176 (0.57%)  1/176 (0.57%)  2/175 (1.14%)  0/180 (0.00%) 
Abnormal behaviour  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Hallucination, auditory  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Mood altered  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Sleep disorder  1  1/176 (0.57%)  2/176 (1.14%)  0/175 (0.00%)  0/180 (0.00%) 
Affective disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Agitation  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Anxiety disorder  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Confusional arousal  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Emotional disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Expressive language disorder  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Fear  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Impatience  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Nervousness  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Obsessive-compulsive disorder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Personality change  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Personality disorder  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Regressive behaviour  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Restlessness  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Self-injurious ideation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Sleep talking  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Soliloquy  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Stubbornness  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Suicide attempt  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Thinking abnormal  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Tic  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Abnormal dreams  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Acute stress disorder  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Intentional self-injury  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Panic attack  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Renal and urinary disorders         
Dysuria  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Bladder irritation  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Calculus ureteric  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Hypertonic bladder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Nephrolithiasis  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Neurogenic bladder  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Nocturia  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Polyuria  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Proteinuria  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Urinary incontinence  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Haematuria  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Pollakiuria  1  2/176 (1.14%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Reproductive system and breast disorders         
Prostatitis  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Cervical cyst  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Cervical polyp  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Hypomenorrhoea  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Menorrhagia  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Menstrual disorder  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Menstruation irregular  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Pelvic fluid collection  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Scrotal swelling  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dysmenorrhoea  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/176 (0.00%)  2/176 (1.14%)  0/175 (0.00%)  2/180 (1.11%) 
Epistaxis  1  1/176 (0.57%)  1/176 (0.57%)  1/175 (0.57%)  0/180 (0.00%) 
Rhinitis allergic  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  1/180 (0.56%) 
Upper respiratory tract inflammation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Cough  1  2/176 (1.14%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Dyspnoea  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Hiccups  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Productive cough  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Rhinorrhoea  1  3/176 (1.70%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Sneezing  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Wheezing  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  2/176 (1.14%)  2/176 (1.14%)  2/175 (1.14%)  9/180 (5.00%) 
Pruritus  1  1/176 (0.57%)  1/176 (0.57%)  4/175 (2.29%)  2/180 (1.11%) 
Eczema  1  2/176 (1.14%)  1/176 (0.57%)  1/175 (0.57%)  2/180 (1.11%) 
Dermatitis  1  1/176 (0.57%)  1/176 (0.57%)  1/175 (0.57%)  1/180 (0.56%) 
Urticaria  1  4/176 (2.27%)  0/176 (0.00%)  1/175 (0.57%)  2/180 (1.11%) 
Heat rash  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  1/180 (0.56%) 
Acne  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Blister  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Dermatitis allergic  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dermatitis atopic  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dermatitis contact  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Dry skin  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Eczema asteatotic  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Erythema  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Pityriasis alba  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Rash erythematous  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Rash papular  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Rash pruritic  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Skin burning sensation  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Skin erosion  1  0/176 (0.00%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Skin ulcer  1  0/176 (0.00%)  0/176 (0.00%)  1/175 (0.57%)  0/180 (0.00%) 
Alopecia  1  3/176 (1.70%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Night sweats  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
Vascular disorders         
Hypertension  1  1/176 (0.57%)  1/176 (0.57%)  0/175 (0.00%)  0/180 (0.00%) 
Hypotension  1  0/176 (0.00%)  0/176 (0.00%)  0/175 (0.00%)  1/180 (0.56%) 
Angiodysplasia  1  1/176 (0.57%)  0/176 (0.00%)  0/175 (0.00%)  0/180 (0.00%) 
1
Term from vocabulary, 13.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Inquiry Service.
Organization: Eisai Co., Ltd.
EMail: eisai-chiken_hotline@hhc.eisai.co.jp
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01618695    
Other Study ID Numbers: E2007-J000-335
First Submitted: June 11, 2012
First Posted: June 13, 2012
Results First Submitted: May 20, 2020
Results First Posted: June 5, 2020
Last Update Posted: July 15, 2020