Trial Outcomes & Findings for Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method (NCT NCT00160615)

NCT ID: NCT00160615

Last Updated: 2019-06-10

Results Overview

Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 154 participants
• Primary outcome timeframe: From Baseline up to 54 months
• Results posted on: 2019-06-10

Participant Flow

The study started to enroll patients in September 2001 and concluded in January 2007.

Participant Flow refers to the Full Analysis Set (FAS). Of the 154 subjects who enrolled in the study, 151 subjects were included in the FAS population and 3 subjects were identified with major protocol deviations leading to exclusion from FAS.

Participant milestones

Measure	N165 Randomized Treatment PBO Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Study STARTED	50	101
Overall Study COMPLETED	32	56
Overall Study NOT COMPLETED	18	45

Reasons for withdrawal

Measure	N165 Randomized Treatment PBO Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Overall Study Adverse Event	5	12
Overall Study Withdrawal by Subject	0	2
Overall Study Lack of Efficacy	11	23
Overall Study Patient decision	1	2
Overall Study Investigator decision	1	1
Overall Study AE agents had to be discontinued (exam.)	0	1
Overall Study Switch to surgical treatment	0	2
Overall Study Non-compliance was suspected	0	1
Overall Study Poor compliance	0	1

Baseline Characteristics

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Baseline characteristics by cohort

Measure	N165 Randomized Treatment PBO (FAS) n=50 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV (FAS) n=101 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	Total Title n=151 Participants
Age, Continuous	33.19 Years STANDARD_DEVIATION 9.99 • n=5 Participants	31.95 Years STANDARD_DEVIATION 10.19 • n=7 Participants	32.36 Years STANDARD_DEVIATION 10.11 • n=5 Participants
Age, Customized <=18 years	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized Between 18 and 65 years	48 Participants n=5 Participants	95 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	47 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	54 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to 54 months

Population: Full Analysis set included 151 subjects. Only subjects with valid data for partial (Type I) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

Outcome measures

Measure	N165 Randomized Treatment PBO n=50 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=101 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Partial (Type I) Seizure Frequency Per Week by Analysis Visit >= 1 day(d) - <= 3 months(m)	1.68 Number of Seizures (Type I) per week Interval 1.18 to 4.06	2.19 Number of Seizures (Type I) per week Interval 0.99 to 5.41
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 3 m - <= 6 m	1.69 Number of Seizures (Type I) per week Interval 1.0 to 2.75	2.00 Number of Seizures (Type I) per week Interval 0.87 to 4.48
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 6 m - <= 9 m	1.58 Number of Seizures (Type I) per week Interval 0.88 to 2.69	1.78 Number of Seizures (Type I) per week Interval 0.68 to 4.94
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 9 m - <= 12 m	1.41 Number of Seizures (Type I) per week Interval 0.95 to 3.25	1.60 Number of Seizures (Type I) per week Interval 0.6 to 5.05
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 12 m - <= 15 m	1.58 Number of Seizures (Type I) per week Interval 1.06 to 2.5	1.55 Number of Seizures (Type I) per week Interval 0.8 to 4.67
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 15 m - <= 18 m	1.36 Number of Seizures (Type I) per week Interval 1.03 to 2.32	1.69 Number of Seizures (Type I) per week Interval 0.75 to 4.8
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 18 m - <= 21 m	1.35 Number of Seizures (Type I) per week Interval 0.72 to 1.96	1.51 Number of Seizures (Type I) per week Interval 0.62 to 4.49
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 21 m - <= 24 m	1.30 Number of Seizures (Type I) per week Interval 0.75 to 1.98	1.36 Number of Seizures (Type I) per week Interval 0.67 to 3.17
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 24 m - <= 27 m	1.25 Number of Seizures (Type I) per week Interval 0.56 to 2.38	1.33 Number of Seizures (Type I) per week Interval 0.82 to 2.8
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 27 m - <= 30 m	1.30 Number of Seizures (Type I) per week Interval 0.66 to 2.46	1.28 Number of Seizures (Type I) per week Interval 0.72 to 2.75
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 30 m - <= 33 m	1.21 Number of Seizures (Type I) per week Interval 0.71 to 2.65	1.33 Number of Seizures (Type I) per week Interval 0.77 to 2.83
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 33 m - <= 36 m	1.14 Number of Seizures (Type I) per week Interval 0.68 to 2.69	1.30 Number of Seizures (Type I) per week Interval 0.71 to 3.31
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 36 m - <= 39 m	1.20 Number of Seizures (Type I) per week Interval 0.65 to 2.92	1.28 Number of Seizures (Type I) per week Interval 0.75 to 3.32
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 39 m - <= 42 m	1.25 Number of Seizures (Type I) per week Interval 0.5 to 2.91	1.32 Number of Seizures (Type I) per week Interval 0.58 to 2.62
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 42 m - <= 45 m	1.17 Number of Seizures (Type I) per week Interval 0.79 to 2.41	1.28 Number of Seizures (Type I) per week Interval 0.6 to 2.49
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 45 m - <= 48 m	0.95 Number of Seizures (Type I) per week Interval 0.54 to 2.05	1.09 Number of Seizures (Type I) per week Interval 0.25 to 1.58
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 48 m - <= 51 m	0.90 Number of Seizures (Type I) per week Interval 0.31 to 1.61	0.70 Number of Seizures (Type I) per week Interval 0.14 to 1.42
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 51 m - <= 54 m	1.06 Number of Seizures (Type I) per week Interval 0.08 to 2.17	0.78 Number of Seizures (Type I) per week Interval 0.11 to 1.33
Partial (Type I) Seizure Frequency Per Week by Analysis Visit > 54 m	1.16 Number of Seizures (Type I) per week Interval 0.27 to 1.65	0.09 Number of Seizures (Type I) per week Interval 0.08 to 1.16

PRIMARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

Outcome measures

Measure	N165 Randomized Treatment PBO n=23 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=61 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit >= 1 d - <= 3 m	0.86 Number of Seizures (Type IA) per week Interval 0.07 to 1.73	0.68 Number of Seizures (Type IA) per week Interval 0.06 to 4.41
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 3 m - <= 6 m	0.32 Number of Seizures (Type IA) per week Interval 0.06 to 1.44	0.83 Number of Seizures (Type IA) per week Interval 0.06 to 3.31
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 6 m - <= 9 m	0.24 Number of Seizures (Type IA) per week Interval 0.0 to 1.33	0.63 Number of Seizures (Type IA) per week Interval 0.05 to 4.67
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 9 m - <= 12 m	0.26 Number of Seizures (Type IA) per week Interval 0.0 to 1.23	0.50 Number of Seizures (Type IA) per week Interval 0.0 to 3.47
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 12 m - <= 15 m	0.57 Number of Seizures (Type IA) per week Interval 0.09 to 1.35	0.22 Number of Seizures (Type IA) per week Interval 0.0 to 2.74
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 15 m - <= 18 m	0.27 Number of Seizures (Type IA) per week Interval 0.0 to 1.32	0.30 Number of Seizures (Type IA) per week Interval 0.0 to 2.81
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 18 m - <= 21 m	0.10 Number of Seizures (Type IA) per week Interval 0.0 to 1.38	0.42 Number of Seizures (Type IA) per week Interval 0.0 to 1.82
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 21 m - <= 24 m	0.17 Number of Seizures (Type IA) per week Interval 0.06 to 1.0	0.43 Number of Seizures (Type IA) per week Interval 0.05 to 1.6
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 24 m - <= 27 m	0.29 Number of Seizures (Type IA) per week Interval 0.0 to 1.1	0.25 Number of Seizures (Type IA) per week Interval 0.0 to 1.41
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 27 m - <= 30 m	0.44 Number of Seizures (Type IA) per week Interval 0.0 to 1.06	0.17 Number of Seizures (Type IA) per week Interval 0.0 to 1.41
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 30 m - <= 33 m	0.24 Number of Seizures (Type IA) per week Interval 0.0 to 0.98	0.25 Number of Seizures (Type IA) per week Interval 0.08 to 1.32
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 33 m - <= 36 m	0.17 Number of Seizures (Type IA) per week Interval 0.0 to 0.83	0.29 Number of Seizures (Type IA) per week Interval 0.05 to 1.63
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 36 m - <= 39 m	0.14 Number of Seizures (Type IA) per week Interval 0.0 to 0.4	0.13 Number of Seizures (Type IA) per week Interval 0.04 to 1.5
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 39 m - <= 42 m	0.17 Number of Seizures (Type IA) per week Interval 0.0 to 0.83	0.28 Number of Seizures (Type IA) per week Interval 0.04 to 1.29
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 42 m - <= 45 m	0.09 Number of Seizures (Type IA) per week Interval 0.0 to 1.13	0.44 Number of Seizures (Type IA) per week Interval 0.08 to 1.03
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 45 m - <= 48 m	0.20 Number of Seizures (Type IA) per week Interval 0.08 to 0.97	0.48 Number of Seizures (Type IA) per week Interval 0.09 to 1.38
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 48 m - <= 51 m	0.44 Number of Seizures (Type IA) per week Interval 0.0 to 1.42	0.18 Number of Seizures (Type IA) per week Interval 0.0 to 1.17
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 51 m - <= 54 m	0.62 Number of Seizures (Type IA) per week Interval 0.0 to 1.59	0.17 Number of Seizures (Type IA) per week Interval 0.1 to 0.63
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit > 54 m	0.87 Number of Seizures (Type IA) per week Interval 0.14 to 1.65	0.08 Number of Seizures (Type IA) per week Interval 0.0 to 0.84

PRIMARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

Outcome measures

Measure	N165 Randomized Treatment PBO n=44 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=91 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit >= 1 d - <= 3 m	1.56 Number of Seizures (Type IB) per week Interval 0.94 to 2.49	1.27 Number of Seizures (Type IB) per week Interval 0.5 to 3.25
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 3 m - <= 6 m	1.51 Number of Seizures (Type IB) per week Interval 0.81 to 2.69	1.13 Number of Seizures (Type IB) per week Interval 0.38 to 3.18
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 6 m <= 9 m	1.30 Number of Seizures (Type IB) per week Interval 0.6 to 2.25	0.92 Number of Seizures (Type IB) per week Interval 0.25 to 2.31
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 9 m - <= 12 m	1.39 Number of Seizures (Type IB) per week Interval 0.8 to 1.88	0.72 Number of Seizures (Type IB) per week Interval 0.24 to 2.11
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 12 m - <= 15 m	1.34 Number of Seizures (Type IB) per week Interval 0.71 to 1.94	0.81 Number of Seizures (Type IB) per week Interval 0.38 to 2.12
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 15 m - <= 18 m	1.25 Number of Seizures (Type IB) per week Interval 0.81 to 2.21	0.81 Number of Seizures (Type IB) per week Interval 0.35 to 1.88
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 18 m - <= 21 m	1.25 Number of Seizures (Type IB) per week Interval 0.72 to 1.95	0.58 Number of Seizures (Type IB) per week Interval 0.31 to 2.34
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 21 m - <= 24 m	1.26 Number of Seizures (Type IB) per week Interval 0.7 to 1.9	0.73 Number of Seizures (Type IB) per week Interval 0.26 to 2.65
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 24 m - <= 27 m	1.21 Number of Seizures (Type IB) per week Interval 0.56 to 2.5	0.85 Number of Seizures (Type IB) per week Interval 0.13 to 2.05
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 27 m - <= 30 m	1.21 Number of Seizures (Type IB) per week Interval 0.66 to 3.33	0.98 Number of Seizures (Type IB) per week Interval 0.15 to 1.74
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 30 m - <= 33 m	1.25 Number of Seizures (Type IB) per week Interval 0.69 to 2.84	0.79 Number of Seizures (Type IB) per week Interval 0.2 to 2.04
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 33 m - <= 36 m	1.15 Number of Seizures (Type IB) per week Interval 0.76 to 2.91	0.96 Number of Seizures (Type IB) per week Interval 0.14 to 2.13
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 36 m - <= 39 m	1.28 Number of Seizures (Type IB) per week Interval 0.8 to 3.43	1.04 Number of Seizures (Type IB) per week Interval 0.17 to 2.48
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 39 m - <= 42 m	1.40 Number of Seizures (Type IB) per week Interval 0.66 to 3.48	0.77 Number of Seizures (Type IB) per week Interval 0.13 to 1.71
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 42 m - <= 45 m	1.22 Number of Seizures (Type IB) per week Interval 0.76 to 2.79	0.89 Number of Seizures (Type IB) per week Interval 0.08 to 1.52
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 45 m - <= 48 m	0.87 Number of Seizures (Type IB) per week Interval 0.46 to 2.89	0.27 Number of Seizures (Type IB) per week Interval 0.0 to 1.36
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 48 m - <= 51 m	0.74 Number of Seizures (Type IB) per week Interval 0.33 to 2.46	0.22 Number of Seizures (Type IB) per week Interval 0.02 to 1.15
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 51 m - <= 54 m	0.80 Number of Seizures (Type IB) per week Interval 0.46 to 3.64	0.19 Number of Seizures (Type IB) per week Interval 0.0 to 1.25
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit > 54 m	0.72 Number of Seizures (Type IB) per week Interval 0.54 to 1.33	0.09 Number of Seizures (Type IB) per week Interval 0.0 to 0.17

PRIMARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

Outcome measures

Measure	N165 Randomized Treatment PBO n=18 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=42 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 48 m - <= 51 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.04	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit >= 1 d - <= 3 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.31	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.19
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 3 m - <= 6 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.13	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.07
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 6 m - <= 9 m	0.05 Number of Seizures (Type IC) per week Interval 0.0 to 0.19	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.13
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 9 m - <= 12 m	0.06 Number of Seizures (Type IC) per week Interval 0.0 to 0.17	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.06
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 12 m - <= 15 m	0.06 Number of Seizures (Type IC) per week Interval 0.0 to 0.07	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.03
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 15 m - <= 18 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.13	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.06
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 18 m - <= 21 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.17	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 21 m - <= 24 m	0.05 Number of Seizures (Type IC) per week Interval 0.0 to 0.14	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 24 m - <= 27 m	0.02 Number of Seizures (Type IC) per week Interval 0.0 to 0.17	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 27 m - <= 30 m	0.04 Number of Seizures (Type IC) per week Interval 0.0 to 0.13	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 30 m - <= 33 m	0.09 Number of Seizures (Type IC) per week Interval 0.0 to 0.16	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 33 m - <= 36 m	0.06 Number of Seizures (Type IC) per week Interval 0.0 to 0.13	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 36 m - <= 39 m	0.04 Number of Seizures (Type IC) per week Interval 0.0 to 0.08	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 39 m - <= 42 m	0.08 Number of Seizures (Type IC) per week Interval 0.0 to 0.08	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 42 m - <= 45 m	0.04 Number of Seizures (Type IC) per week Interval 0.0 to 0.19	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.02
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 45 m - <= 48 m	0.02 Number of Seizures (Type IC) per week Interval 0.0 to 0.04	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 51 m - <= 54 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit > 54 m	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0	0.00 Number of Seizures (Type IC) per week Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From Baseline up to 54 months

Population: Full Analysis set included 151 subjects. Only subjects with valid data for Partial (Type I seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.

Outcome measures

Measure	N165 Randomized Treatment PBO n=50 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=101 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit >= 1 d - <= 3 m	-27.39 Percent change Interval -48.11 to 5.37	-31.24 Percent change Interval -61.33 to 2.86
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 3 m - <= 6 m	-35.15 Percent change Interval -58.61 to -6.2	-34.74 Percent change Interval -62.48 to -3.22
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 6 m - <= 9 m	-38.42 Percent change Interval -59.44 to 5.08	-43.03 Percent change Interval -77.38 to -9.61
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 9 m - <= 12 m	-41.44 Percent change Interval -61.3 to -6.63	-43.11 Percent change Interval -73.76 to -11.6
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 12 m - <= 15 m	-29.58 Percent change Interval -58.69 to -10.04	-46.38 Percent change Interval -73.8 to -11.12
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 15 m - <= 18 m	-44.44 Percent change Interval -70.68 to -19.37	-43.17 Percent change Interval -69.33 to -16.84
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 18 m - <= 21 m	-37.58 Percent change Interval -69.96 to -21.23	-49.61 Percent change Interval -71.95 to -20.04
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 21 m - <= 24 m	-45.75 Percent change Interval -59.76 to -15.74	-52.96 Percent change Interval -77.16 to -13.78
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 24 m - <= 27 m	-50.89 Percent change Interval -69.36 to 0.01	-53.78 Percent change Interval -73.22 to -23.05
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 27 m - <= 30 m	-40.54 Percent change Interval -74.09 to -1.74	-47.71 Percent change Interval -76.29 to -18.07
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 30 m - <= 33 m	-29.96 Percent change Interval -69.05 to 0.0	-43.09 Percent change Interval -76.8 to -16.09
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 33 m - <= 36 m	-40.03 Percent change Interval -72.14 to -5.33	-39.01 Percent change Interval -75.01 to -11.31
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 36 m - <= 39 m	-43.67 Percent change Interval -68.7 to 3.89	-44.42 Percent change Interval -74.06 to -9.63
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 39 m - <= 42 m	-42.88 Percent change Interval -65.68 to 0.2	-47.69 Percent change Interval -85.88 to -10.34
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 42 m - <= 45 m	-45.06 Percent change Interval -57.76 to -21.01	-71.96 Percent change Interval -85.97 to -21.29
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 45 m - <= 48 m	-42.41 Percent change Interval -71.81 to -28.73	-80.02 Percent change Interval -86.42 to -36.37
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 48 m - <= 51 m	-49.11 Percent change Interval -74.26 to -23.92	-78.28 Percent change Interval -88.06 to -55.91
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 51 m - <= 54 m	-43.74 Percent change Interval -96.55 to 0.6	-81.81 Percent change Interval -92.97 to -66.12
Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit > 54 m	-40.72 Percent change Interval -76.94 to -14.12	-90.00 Percent change Interval -92.17 to -85.37

SECONDARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IA seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IA) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.

Outcome measures

Measure	N165 Randomized Treatment PBO n=23 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=61 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit >= 1 d - <= 3 m	-79.58 Percent change Interval -89.22 to -24.55	-45.93 Percent change Interval -88.28 to 14.97
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 3 m - <= 6 m	-77.15 Percent change Interval -95.81 to -43.42	-58.81 Percent change Interval -83.66 to 9.91
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 6 m - <= 9 m	-71.71 Percent change Interval -100.0 to -39.06	-61.62 Percent change Interval -86.96 to 45.98
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 9 m - <= 12 m	-66.05 Percent change Interval -100.0 to -42.98	-69.01 Percent change Interval -99.09 to -24.55
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 12 m - <= 15 m	-37.32 Percent change Interval -96.72 to -19.64	-78.44 Percent change Interval -100.0 to -43.42
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 15 m - <= 18 m	-79.55 Percent change Interval -100.0 to -46.11	-71.42 Percent change Interval -93.19 to -9.46
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 18 m - <= 21 m	-83.68 Percent change Interval -100.0 to -39.59	-66.07 Percent change Interval -97.31 to -19.52
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 21 m - <= 24 m	-82.30 Percent change Interval -99.71 to -50.87	-73.18 Percent change Interval -87.28 to -7.74
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 24 m - <= 27 m	-72.52 Percent change Interval -99.68 to -49.91	-74.85 Percent change Interval -91.27 to -33.43
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 27 m - <= 30 m	-74.89 Percent change Interval -98.71 to -46.15	-76.45 Percent change Interval -95.81 to -12.09
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 30 m - <= 33 m	-80.89 Percent change Interval -98.97 to -48.35	-78.24 Percent change Interval -89.74 to -4.31
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 33 m - <= 36 m	-84.13 Percent change Interval -100.0 to -48.15	-80.40 Percent change Interval -96.99 to 9.85
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 36 m - <= 39 m	-90.62 Percent change Interval -100.0 to -53.87	-76.79 Percent change Interval -97.71 to -27.78
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 39 m - <= 42 m	-92.50 Percent change Interval -100.0 to -42.88	-75.66 Percent change Interval -96.1 to -18.07
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 42 m - <= 45 m	-77.00 Percent change Interval -99.57 to -47.52	-74.09 Percent change Interval -93.06 to -39.64
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 45 m - <= 48 m	-71.43 Percent change Interval -91.25 to -47.31	-79.25 Percent change Interval -95.95 to -41.45
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 48 m - <= 51 m	-54.01 Percent change Interval -95.64 to -48.88	-91.41 Percent change Interval -100.0 to -56.26
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 51 m - <= 54 m	-64.18 Percent change Interval -100.0 to -42.73	-83.37 Percent change Interval -98.18 to -71.43
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit > 54 m	-59.19 Percent change Interval -92.21 to -32.87	-97.55 Percent change Interval -100.0 to -85.71

SECONDARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IB seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IB) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.

Outcome measures

Measure	N165 Randomized Treatment PBO n=44 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=91 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit >= 1 d - <= 3 m	-21.41 Percent change Interval -48.68 to 19.61	-26.77 Percent change Interval -57.3 to 6.25
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 3 m - <= 6 m	-21.95 Percent change Interval -52.22 to 2.27	-31.35 Percent change Interval -64.47 to 0.53
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 6 m - <= 9 m	-28.30 Percent change Interval -52.22 to 7.3	-47.61 Percent change Interval -75.99 to -7.14
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 9 m - <= 12 m	-34.97 Percent change Interval -50.02 to 17.7	-43.56 Percent change Interval -73.35 to -14.31
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 12 m - <= 15 m	-21.12 Percent change Interval -54.73 to 7.78	-51.20 Percent change Interval -74.85 to 6.18
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 15 m - <= 18 m	-33.18 Percent change Interval -56.67 to 6.88	-45.80 Percent change Interval -66.8 to -12.59
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 18 m - <= 21 m	-32.78 Percent change Interval -54.73 to 2.63	-52.04 Percent change Interval -72.79 to -15.92
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 21 m - <= 24 m	-20.12 Percent change Interval -58.09 to 1.17	-52.96 Percent change Interval -78.82 to -10.93
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 24 m - <= 27 m	-28.75 Percent change Interval -61.84 to 13.15	-49.71 Percent change Interval -72.31 to -17.12
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 27 m - <= 30 m	-8.84 Percent change Interval -51.8 to 3.05	-48.18 Percent change Interval -79.29 to -21.93
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 30 m - <= 33 m	-15.85 Percent change Interval -52.14 to 16.16	-46.86 Percent change Interval -79.88 to -11.48
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 33 m - <= 36 m	-11.73 Percent change Interval -53.45 to 17.68	-42.03 Percent change Interval -74.93 to -6.07
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 36 m - <= 39 m	-15.06 Percent change Interval -49.4 to 28.76	-46.25 Percent change Interval -76.15 to 7.85
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 39 m - <= 42 m	-20.13 Percent change Interval -53.31 to 31.25	-49.85 Percent change Interval -86.73 to 0.0
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 42 m - <= 45 m	-23.76 Percent change Interval -46.47 to 13.76	-46.51 Percent change Interval -91.95 to -11.07
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 45 m - <= 48 m	-37.52 Percent change Interval -56.1 to -13.36	-54.05 Percent change Interval -98.11 to -16.56
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 48 m - <= 51 m	-42.17 Percent change Interval -53.57 to 1.7	-77.08 Percent change Interval -94.99 to -38.37
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 51 m - <= 54 m	5.38 Percent change Interval -44.75 to 10.33	-74.58 Percent change Interval -100.0 to 42.13
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit > 54 m	3.55 Percent change Interval -47.49 to 74.45	-86.61 Percent change Interval -93.85 to -8.06

SECONDARY outcome

Timeframe: From Baseline up to 54 months

Population: Subjects with Type IC seizure count equal to zero during baseline and evaluation periods are excluded. Only subjects with valid data for partial (Type IC) seizure frequency per week at the respective visit are included in the analysis. Number of participants analyzed is given separately per visit.

Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.

Negative values indicate improvement from Baseline.

Outcome measures

Measure	N165 Randomized Treatment PBO n=18 Participants Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.	N165 Randomized Treatment LEV n=42 Participants Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit >= 1 d - <= 3 m	-100.00 Percent change Interval -100.0 to -24.55	-100.00 Percent change Interval -100.0 to -32.5
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 3 m - <= 6 m	-93.96 Percent change Interval -100.0 to -59.36	-100.00 Percent change Interval -100.0 to -32.1
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 6 m - <= 9 m	-88.73 Percent change Interval -100.0 to 38.32	-100.00 Percent change Interval -100.0 to -43.42
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 9 m - <= 12 m	-100.00 Percent change Interval -100.0 to -54.73	-100.00 Percent change Interval -100.0 to -40.03
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 12 m - <= 15 m	-88.33 Percent change Interval -100.0 to -49.7	-100.00 Percent change Interval -100.0 to -64.5
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 15 m - <= 18 m	-100.00 Percent change Interval -100.0 to -62.28	-100.00 Percent change Interval -100.0 to -69.82
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 18 m - <= 21 m	-90.42 Percent change Interval -100.0 to -54.73	-100.00 Percent change Interval -100.0 to -25.61
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 21 m - <= 24 m	-80.56 Percent change Interval -100.0 to -24.55	-100.00 Percent change Interval -100.0 to -68.35
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 24 m - <= 27 m	-91.92 Percent change Interval -100.0 to -24.55	-100.00 Percent change Interval -100.0 to -45.54
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 27 m - <= 30 m	-92.11 Percent change Interval -100.0 to -74.85	-100.00 Percent change Interval -100.0 to -45.54
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 30 m - <= 33 m	-77.02 Percent change Interval -95.91 to 16.78	-100.00 Percent change Interval -100.0 to -86.64
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 33 m - <= 36 m	-74.30 Percent change Interval -91.72 to -46.59	-100.00 Percent change Interval -100.0 to -92.19
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 36 m - <= 39 m	-85.67 Percent change Interval -96.25 to -7.06	-100.00 Percent change Interval -100.0 to -83.77
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 39 m - <= 42 m	-83.23 Percent change Interval -100.0 to -21.27	-100.00 Percent change Interval -100.0 to -47.52
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 42 m - <= 45 m	-79.75 Percent change Interval -100.0 to -56.26	-100.00 Percent change Interval -100.0 to -49.7
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 45 m - <= 48 m	-95.81 Percent change Interval -100.0 to -83.23	-100.00 Percent change Interval -100.0 to -85.94
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 48 m - <= 51 m	-95.98 Percent change Interval -100.0 to -87.62	-100.00 Percent change Interval -100.0 to -100.0
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 51 m - <= 54 m	-100.00 Percent change Interval -100.0 to -91.67	-100.00 Percent change Interval -100.0 to -100.0
Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit > 54 m	-100.00 Percent change Interval -100.0 to -100.0	-100.00 Percent change Interval -100.0 to -100.0

Adverse Events

N165 Randomized Treatment PBO (FAS)

Serious events: 12 serious events

Other events: 48 other events

Deaths: 0 deaths

N165 Randomized Treatment LEV (FAS)

Serious events: 22 serious events

Other events: 99 other events

Deaths: 1 deaths

Serious adverse events

Measure	N165 Randomized Treatment PBO (FAS) n=50 participants at risk Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. In the Placebo group the Serious Adverse Events (SAEs) Status epilepticus and Agitation occurred twice in 2 subjects.	N165 Randomized Treatment LEV (FAS) n=101 participants at risk Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Infections and infestations Appendicitis	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Abdominal pain lower	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Enterocolitis	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Gastric polyps	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Difficulty in walking	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Drowning	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Hyperthermia	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Hepatobiliary disorders Gallbladder polyp	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Contusion	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Fall	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Nasopharyngitis	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Pneumonia	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Pyelonephritis acute	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Femoral neck fracture	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Fractured sacrum	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Head injury	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Neck injury	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Polytraumatism	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Convulsion	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.0% 5/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Dyslalia	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Grand mal convulsion	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Status epilepticus	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	4.0% 4/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Pregnancy, puerperium and perinatal conditions Pregnancy	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Psychiatric disorders Agitation	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Psychiatric disorders Mental disorder	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Surgical and medical procedures Abortion induced	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.00% 0/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Surgical and medical procedures Mass excision	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).

Other adverse events

Measure	N165 Randomized Treatment PBO (FAS) n=50 participants at risk Subjects received Placebo (PBO) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day. In the Placebo group the Serious Adverse Events (SAEs) Status epilepticus and Agitation occurred twice in 2 subjects.	N165 Randomized Treatment LEV (FAS) n=101 participants at risk Subjects received Levetiracetam (LEV) in study N165 \[NCT00600509\] and received LEV in this study: After starting with the 4 week-fixed 3000 mg/day, the daily doses of LEV were permitted to be adjusted by 500 or 1000 mg/day at a 4-week interval between 1000 mg/day and 3000 mg/day.
Eye disorders Conjunctivitis	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Eye disorders Diplopia	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Abdominal pain	14.0% 7/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Abdominal pain upper	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	8.9% 9/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Cheilitis	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Constipation	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	19.8% 20/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Diarrhoea	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	26.7% 27/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Gastritis	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Gingivitis	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Nausea	12.0% 6/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	12.9% 13/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Stomatitis	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	10.9% 11/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Toothache	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.0% 5/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Gastrointestinal disorders Vomiting	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	12.9% 13/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Chest pain	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Malaise	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
General disorders Pyrexia	18.0% 9/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	13.9% 14/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Immune system disorders Seasonal allergy	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	4.0% 4/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Dental caries	12.0% 6/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	12.9% 13/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Influenza	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Nasopharyngitis	76.0% 38/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	75.2% 76/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Infections and infestations Pharyngitis	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Arthropod sting	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Contusion	32.0% 16/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	28.7% 29/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Excoriation	18.0% 9/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	17.8% 18/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Joint sprain	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Mouth injury	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Open wound	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Skin laceration	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	13.9% 14/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Injury, poisoning and procedural complications Thermal burn	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	9.9% 10/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Blood alkaline phosphatase increased	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Blood triglycerides increased	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Blood urine present	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Gamma-glutamyltransferase increased	16.0% 8/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	15.8% 16/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Glucose urine present	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Neutrophil count decreased	0.00% 0/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Protein urine present	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Weight decreased	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	8.9% 9/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations Weight increased	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Investigations White blood cell count increased	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Metabolism and nutrition disorders Decreased appetite	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Musculoskeletal and connective tissue disorders Back pain	14.0% 7/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	10.9% 11/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Musculoskeletal and connective tissue disorders Myalgia	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Musculoskeletal and connective tissue disorders Shoulder pain	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Convulsion	40.0% 2/5 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	8.9% 9/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Dizziness	24.0% 12/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	19.8% 20/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Epilepsy	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.9% 6/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Headache	32.0% 16/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	27.7% 28/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Hypoaesthesia	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	4.0% 4/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Migraine	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	0.99% 1/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Somnolence	26.0% 13/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	24.8% 25/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Nervous system disorders Tremor	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Psychiatric disorders Insomnia	16.0% 8/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	12.9% 13/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Renal and urinary disorders Pollakiuria	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.0% 5/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Reproductive system and breast disorders Dysmenorrhoea	2.0% 1/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Cough	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	6.9% 7/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	2.0% 2/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.0% 3/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	5.0% 5/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	24.0% 12/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	21.8% 22/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Skin and subcutaneous tissue disorders Acne	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Skin and subcutaneous tissue disorders Eczema	10.0% 5/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	13.9% 14/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Skin and subcutaneous tissue disorders Pruritus	8.0% 4/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	3.0% 3/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).
Skin and subcutaneous tissue disorders Rash	4.0% 2/50 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).	7.9% 8/101 • Adverse events were collected from Visit 1 (Week 0) until 2 weeks after termination (up to 54 months). Adverse events refer to the Full Analysis Set (FAS).

Additional Information

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Results disclosure agreements

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

Restriction type: GT60