Trial Outcomes & Findings for An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy (NCT NCT00505284)

Last Updated: 2014-07-11

Results Overview

Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

352 participants

Primary outcome timeframe

Baseline to Week 15/EOT

Results posted on

2014-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo	Perampanel 2mg (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Overall Study STARTED	73	72	69	68	70
Overall Study COMPLETED	63	56	57	49	37
Overall Study NOT COMPLETED	10	16	12	19	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	Perampanel 2mg (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Overall Study Adverse Event	3	7	9	14	22
Overall Study Protocol Violation	0	1	1	0	0
Overall Study Withdrawal by Subject	2	6	1	0	6
Overall Study Lack of Efficacy	0	1	1	1	1
Overall Study Physician Decision	0	1	0	0	0
Overall Study Other	5	0	0	4	4

Baseline Characteristics

An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=71 Participants	Perampanel 2mg n=71 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=68 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=67 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)	Total n=345 Participants Total of all reporting groups
Age, Customized <65 years	50 Participants n=93 Participants	50 Participants n=4 Participants	40 Participants n=27 Participants	34 Participants n=483 Participants	41 Participants n=36 Participants	215 Participants n=10 Participants
Age, Customized >=65 years	21 Participants n=93 Participants	21 Participants n=4 Participants	28 Participants n=27 Participants	33 Participants n=483 Participants	27 Participants n=36 Participants	130 Participants n=10 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	27 Participants n=4 Participants	28 Participants n=27 Participants	34 Participants n=483 Participants	25 Participants n=36 Participants	151 Participants n=10 Participants
Sex: Female, Male Male	34 Participants n=93 Participants	44 Participants n=4 Participants	40 Participants n=27 Participants	33 Participants n=483 Participants	43 Participants n=36 Participants	194 Participants n=10 Participants
Race/Ethnicity, Customized White	56 participants n=93 Participants	56 participants n=4 Participants	56 participants n=27 Participants	60 participants n=483 Participants	60 participants n=36 Participants	288 participants n=10 Participants
Race/Ethnicity, Customized Black	8 participants n=93 Participants	11 participants n=4 Participants	4 participants n=27 Participants	4 participants n=483 Participants	6 participants n=36 Participants	33 participants n=10 Participants
Race/Ethnicity, Customized Asian	4 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants	0 participants n=483 Participants	0 participants n=36 Participants	7 participants n=10 Participants
Race/Ethnicity, Customized Other	3 participants n=93 Participants	3 participants n=4 Participants	6 participants n=27 Participants	3 participants n=483 Participants	2 participants n=36 Participants	17 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline to Week 15/EOT

Population: Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)	-2.22 Scores on a Scale Standard Deviation 2.19	-1.73 Scores on a Scale Standard Deviation 2.34	-1.30 Scores on a Scale Standard Deviation 2.18	-1.85 Scores on a Scale Standard Deviation 2.01	-1.18 Scores on a Scale Standard Deviation 2.00

PRIMARY outcome

Timeframe: Baseline to Week 15/EOT

Population: ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.

Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score Non-responders (No)	43.7 Percentage of Participants	63.4 Percentage of Participants	67.6 Percentage of Participants	60.6 Percentage of Participants	68.1 Percentage of Participants
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score Responders (Yes)	56.3 Percentage of Participants	36.6 Percentage of Participants	32.4 Percentage of Participants	39.4 Percentage of Participants	31.9 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline to Week 15/EOT

Population: ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score Responders (Yes)	38 Percentage of Participants	23.9 Percentage of Participants	22.1 Percentage of Participants	30.3 Percentage of Participants	18.8 Percentage of Participants
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score Non-responders (No)	62 Percentage of Participants	76.1 Percentage of Participants	77.9 Percentage of Participants	69.7 Percentage of Participants	81.2 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline, Week 1 to Week 17

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 17	NA Scores on a Scale Standard Deviation NA Data unavailable for some arms due to end of study.	-5.50 Scores on a Scale Standard Deviation 3.33	NA Scores on a Scale Standard Deviation NA Data unavailable for some arms due to end of study.	NA Scores on a Scale Standard Deviation NA Data unavailable for some arms due to end of study.	0.71 Scores on a Scale Standard Deviation NA Data unavailable for some arms due to end of study.
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 9	-2.19 Scores on a Scale Standard Deviation 2.10	-1.86 Scores on a Scale Standard Deviation 2.14	-1.76 Scores on a Scale Standard Deviation 2.19	-2.28 Scores on a Scale Standard Deviation 2.12	-2.01 Scores on a Scale Standard Deviation 2.31
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 10	-2.30 Scores on a Scale Standard Deviation 1.96	-1.88 Scores on a Scale Standard Deviation 2.19	-1.84 Scores on a Scale Standard Deviation 2.12	-2.04 Scores on a Scale Standard Deviation 1.98	-1.92 Scores on a Scale Standard Deviation 2.08
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 15	-2.39 Scores on a Scale Standard Deviation 2.23	-1.99 Scores on a Scale Standard Deviation 2.39	-1.58 Scores on a Scale Standard Deviation 2.16	-2.36 Scores on a Scale Standard Deviation 1.91	-1.93 Scores on a Scale Standard Deviation 2.23
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 12	-2.46 Scores on a Scale Standard Deviation 1.99	-1.81 Scores on a Scale Standard Deviation 2.31	-1.76 Scores on a Scale Standard Deviation 2.16	-2.13 Scores on a Scale Standard Deviation 2.11	-1.91 Scores on a Scale Standard Deviation 2.16
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 13	-2.36 Scores on a Scale Standard Deviation 2.00	-1.80 Scores on a Scale Standard Deviation 2.16	-1.62 Scores on a Scale Standard Deviation 2.29	-2.23 Scores on a Scale Standard Deviation 1.99	-2.01 Scores on a Scale Standard Deviation 2.17
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 14	-2.30 Scores on a Scale Standard Deviation 2.17	-1.84 Scores on a Scale Standard Deviation 2.31	-1.56 Scores on a Scale Standard Deviation 2.27	-2.25 Scores on a Scale Standard Deviation 2.00	-1.89 Scores on a Scale Standard Deviation 2.19
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 5	-1.49 Scores on a Scale Standard Deviation 1.71	-1.55 Scores on a Scale Standard Deviation 2.21	-1.12 Scores on a Scale Standard Deviation 2.08	-1.93 Scores on a Scale Standard Deviation 1.96	-1.56 Scores on a Scale Standard Deviation 1.94
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 1	-0.58 Scores on a Scale Standard Deviation 1.46	-0.71 Scores on a Scale Standard Deviation 1.33	-0.58 Scores on a Scale Standard Deviation 1.39	-0.79 Scores on a Scale Standard Deviation 1.44	-0.72 Scores on a Scale Standard Deviation 1.33
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 2	-0.87 Scores on a Scale Standard Deviation 1.65	-1.09 Scores on a Scale Standard Deviation 1.53	-0.80 Scores on a Scale Standard Deviation 1.55	-1.19 Scores on a Scale Standard Deviation 1.71	-1.05 Scores on a Scale Standard Deviation 1.52
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 3	-1.19 Scores on a Scale Standard Deviation 1.85	-1.33 Scores on a Scale Standard Deviation 1.64	-0.91 Scores on a Scale Standard Deviation 1.67	-1.53 Scores on a Scale Standard Deviation 1.92	-1.22 Scores on a Scale Standard Deviation 1.75
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 4	-1.46 Scores on a Scale Standard Deviation 1.73	-1.33 Scores on a Scale Standard Deviation 2.01	-1.10 Scores on a Scale Standard Deviation 1.93	-1.75 Scores on a Scale Standard Deviation 1.99	-1.38 Scores on a Scale Standard Deviation 1.97
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 6	-1.73 Scores on a Scale Standard Deviation 1.81	-1.70 Scores on a Scale Standard Deviation 2.17	-1.31 Scores on a Scale Standard Deviation 2.12	-2.03 Scores on a Scale Standard Deviation 2.14	-1.58 Scores on a Scale Standard Deviation 2.11
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 7	-1.99 Scores on a Scale Standard Deviation 1.96	-1.84 Scores on a Scale Standard Deviation 2.10	-1.50 Scores on a Scale Standard Deviation 2.04	-2.31 Scores on a Scale Standard Deviation 2.32	-1.80 Scores on a Scale Standard Deviation 1.98
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 8	-1.91 Scores on a Scale Standard Deviation 2.01	-1.86 Scores on a Scale Standard Deviation 2.05	-1.72 Scores on a Scale Standard Deviation 2.20	-2.19 Scores on a Scale Standard Deviation 2.23	-1.71 Scores on a Scale Standard Deviation 2.18
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 11	-2.39 Scores on a Scale Standard Deviation 2.03	-1.98 Scores on a Scale Standard Deviation 2.20	-1.85 Scores on a Scale Standard Deviation 2.14	-2.10 Scores on a Scale Standard Deviation 2.09	-1.95 Scores on a Scale Standard Deviation 2.06
Mean Change in Average Pain Scores From Baseline at Each Study Week Week 16	-2.40 Scores on a Scale Standard Deviation 2.38	-2.49 Scores on a Scale Standard Deviation 2.20	-1.50 Scores on a Scale Standard Deviation 2.12	-1.87 Scores on a Scale Standard Deviation 2.12	-1.88 Scores on a Scale Standard Deviation 2.01
Mean Change in Average Pain Scores From Baseline at Each Study Week Last On-Treatment Value	-2.24 Scores on a Scale Standard Deviation 2.18	-1.79 Scores on a Scale Standard Deviation 2.32	-1.48 Scores on a Scale Standard Deviation 2.23	-2.41 Scores on a Scale Standard Deviation 2.15	-1.69 Scores on a Scale Standard Deviation 2.24

SECONDARY outcome

Timeframe: Baseline to Week 15/EOT

Population: ITT Population

Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep \[unable to sleep\]). Based on modified BOCF.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT	-2.17 Scores on a Scale Standard Deviation 2.18	-1.49 Scores on a Scale Standard Deviation 2.11	-1.08 Scores on a Scale Standard Deviation 2.19	-1.71 Scores on a Scale Standard Deviation 2.00	-1.15 Scores on a Scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Baseline and Week 15/EOT

Population: ITT Population

SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT	-5.6 Scores on a Scale Standard Deviation 6.83	-3.9 Scores on a Scale Standard Deviation 6.93	-4.8 Scores on a Scale Standard Deviation 5.83	-6.2 Scores on a Scale Standard Deviation 6.91	-2.9 Scores on a Scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Week 15/EOT

Population: Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.

At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants	Perampanel 2mg n=62 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=66 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=62 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=58 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT Much improved	17 Participants	13 Participants	15 Participants	14 Participants	8 Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT Much worse	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT Very much improved	9 Participants	3 Participants	4 Participants	3 Participants	4 Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT Minimally improved	18 Participants	18 Participants	20 Participants	13 Participants	10 Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT No change	18 Participants	24 Participants	24 Participants	28 Participants	31 Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT Minimally worse	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and Week 15/EOT

Population: ITT Population

Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores Physical Component Score	4.32 Scores on a Scale Standard Deviation 7.43	1.57 Scores on a Scale Standard Deviation 6.35	1.67 Scores on a Scale Standard Deviation 8.21	1.59 Scores on a Scale Standard Deviation 7.92	0.89 Scores on a Scale Standard Deviation 6.86
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores Mental Component Score	-0.26 Scores on a Scale Standard Deviation 9.14	0.40 Scores on a Scale Standard Deviation 8.26	0.06 Scores on a Scale Standard Deviation 10.77	-1.90 Scores on a Scale Standard Deviation 8.74	-1.61 Scores on a Scale Standard Deviation 9.56

SECONDARY outcome

Timeframe: Baseline and Week 15/EOT

Population: ITT Population

HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores Anxiety	-0.5 Scores on a Scale Standard Deviation 3.01	-0.3 Scores on a Scale Standard Deviation 2.85	-0.5 Scores on a Scale Standard Deviation 3.43	-0.5 Scores on a Scale Standard Deviation 2.89	-0.4 Scores on a Scale Standard Deviation 2.71
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores Depression	-0.7 Scores on a Scale Standard Deviation 2.72	-0.4 Scores on a Scale Standard Deviation 2.43	0.0 Scores on a Scale Standard Deviation 3.16	0.1 Scores on a Scale Standard Deviation 3.42	0.2 Scores on a Scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: Baseline and Week 15

Population: ITT Population

Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period Yes (withdrawn)	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period No (Not withdrawn)	73 Participants	71 Participants	68 Participants	67 Participants	69 Participants

SECONDARY outcome

Timeframe: Week 15/EOT

Population: ITT Population

Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Presence or Absence of Allodynia at Week 15/EOT No (Allodynia absent)	47 Participants	45 Participants	47 Participants	48 Participants	44 Participants
Presence or Absence of Allodynia at Week 15/EOT Yes (Allodynia present)	20 Participants	18 Participants	19 Participants	17 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline to Week 15

Population: ITT Population

If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants	Perampanel 2mg n=72 Participants (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=69 Participants (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=68 Participants (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=70 Participants (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period Yes (Used rescue analgesic medication)	13 Participants	9 Participants	10 Participants	10 Participants	13 Participants
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period No (Did not use rescue analgesic medication)	60 Participants	63 Participants	59 Participants	58 Participants	57 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Perampanel 2mg

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Perampanel 4mg

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Perampanel 6mg

Serious events: 8 serious events

Other events: 40 other events

Deaths: 0 deaths

Perampanel 8mg

Serious events: 8 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=71 participants at risk	Perampanel 2mg n=71 participants at risk (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=68 participants at risk (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=67 participants at risk (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=68 participants at risk (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Blood and lymphatic system disorders Anaemia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Cardiac disorders Tachycardia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
General disorders Multi-organ Failure	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
General disorders Death	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Sepsis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	3.0% 2/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Cellulitis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Cystitis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Escherichia Infection	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Labyrinthitis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Osteomyelitis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Pneumonia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Sinusitis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Urinary Tract Infection	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Wound Infection Staphylococcal	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Investigations Blood Pressure Systolic Increased	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Aphasia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Balance Disorder	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Cerebrovascular Accident	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Dizziness	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Encephalopathy	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Syncope	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Psychiatric disorders Homocidal Ideation	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Psychiatric disorders Suicide Attempt	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Renal and urinary disorders Renal Failure Acute	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Renal and urinary disorders Diabetic Neuropathy	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Renal and urinary disorders Urinary Retention	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Blood Pressure Fluctuation	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.

Other adverse events

Other adverse events
Measure	Placebo n=71 participants at risk	Perampanel 2mg n=71 participants at risk (Perampanel 2mg once daily for 15 weeks)	Perampanel 4mg n=68 participants at risk (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)	Perampanel 6mg n=67 participants at risk (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)	Perampanel 8mg n=68 participants at risk (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
Gastrointestinal disorders Diarrhoea	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	3.0% 2/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Gastrointestinal disorders Nausea	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.6% 4/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.5% 5/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.4% 5/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
General disorders Fatigue	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	6.0% 4/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
General disorders Gait Disturbance	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.5% 5/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
General disorders Oedema Peripheral	7.0% 5/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.4% 5/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.5% 3/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Nasopharyngitis	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.4% 5/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Infections and infestations Upper Respiratory Tract Infection	7.0% 5/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.5% 3/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Injury, poisoning and procedural complications Contusion	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	6.0% 4/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.4% 5/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Injury, poisoning and procedural complications Fall	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	10.4% 7/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	10.3% 7/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Investigations Blood Glucose Increased	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.6% 4/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.5% 3/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Investigations Weight Increased	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Musculoskeletal and connective tissue disorders Back Pain	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.6% 4/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	6.0% 4/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.0% 5/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	6.0% 4/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	9.0% 6/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Dizziness	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	8.5% 6/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.9% 2/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	22.4% 15/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	22.1% 15/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Headaches	7.0% 5/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.5% 3/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Nervous system disorders Somnolence	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	2.8% 2/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	13.2% 9/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	7.5% 5/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	16.2% 11/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Psychiatric disorders Insomnia	5.6% 4/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.4% 3/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	4.5% 3/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Vascular disorders Hypertension	4.2% 3/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.4% 1/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	3.0% 2/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	1.5% 1/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.
Vascular disorders Orthostatic Hypotension	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/71 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	5.9% 4/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/67 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.	0.00% 0/68 • Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.

Additional Information

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Principal investigator is a sponsor employee
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