Trial Outcomes & Findings for Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures (NCT NCT01954121)

NCT ID: NCT01954121

Last Updated: 2017-08-15

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

436 participants

Primary outcome timeframe

6-months Evaluation Period (From Week 4 to Week 30)

Results posted on

2017-08-15

Participant Flow

This study started to enroll subjects in China in September 2013.

Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.

Participant milestones

Participant milestones
Measure	Levetiracetam During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Overall Study STARTED	220	216
Overall Study COMPLETED	93	125
Overall Study NOT COMPLETED	127	91

Reasons for withdrawal

Reasons for withdrawal
Measure	Levetiracetam During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Overall Study Lack of Efficacy	94	41
Overall Study Protocol Violation	0	2
Overall Study Lost to Follow-up	5	6
Overall Study Withdrawal by Subject	18	12
Overall Study Pregnancy	1	1
Overall Study AE, serious fatal	1	0
Overall Study AE, non-serious non-fatal	5	22
Overall Study SAE, non-fatal	1	4
Overall Study Non-compliant with study procedures	1	0
Overall Study Non-compliant patient	1	1
Overall Study Subject did not follow instructions	0	2

Baseline Characteristics

Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam (Safety Set) n=218 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Safety Set) n=215 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.	Total Title n=433 Participants
Age, Categorical <=18 years	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	184 Participants n=5 Participants	186 Participants n=7 Participants	370 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous mean (standard deviation)	37.8 years STANDARD_DEVIATION 16.2 • n=5 Participants	33.3 years STANDARD_DEVIATION 14.3 • n=7 Participants	35.6 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	94 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	121 Participants n=7 Participants	233 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-months Evaluation Period (From Week 4 to Week 30)

Population: The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.

Outcome measures

Outcome measures
Measure	Levetiracetam (Per Protocol Set) n=186 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Per Protocol Set) n=171 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period	47.3 percentage of subjects	68.4 percentage of subjects

SECONDARY outcome

Timeframe: From Week 1 to Week 30

Outcome measures

Outcome measures
Measure	Levetiracetam (Per Protocol Set) n=186 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Per Protocol Set) n=171 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period	48.4 percentage of subjects	70.2 percentage of subjects

SECONDARY outcome

Timeframe: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

Outcome measures

Outcome measures
Measure	Levetiracetam (Per Protocol Set) n=186 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Per Protocol Set) n=171 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period	88 events	45 events

SECONDARY outcome

Timeframe: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

Outcome measures

Outcome measures
Measure	Levetiracetam (Per Protocol Set) n=186 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Per Protocol Set) n=171 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Time to First Seizure During the Evaluation Period	87 events	39 events

SECONDARY outcome

Timeframe: From Randomization (Week 1) up to Evaluation Visit (Week 30)

Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

Outcome measures

Outcome measures
Measure	Levetiracetam (Per Protocol Set) n=186 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Per Protocol Set) n=171 Participants During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug	97 events	57 events

Adverse Events

Levetiracetam (Safety Set)

Serious events: 9 serious events

Other events: 92 other events

Deaths: 0 deaths

Carbamazepine-IR (Safety Set)

Serious events: 11 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Levetiracetam (Safety Set) n=218 participants at risk During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Safety Set) n=215 participants at risk During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Infections and infestations Nasopharyngitis	18.3% 40/218 • Number of events 48 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	14.9% 32/215 • Number of events 42 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Infections and infestations Upper respiratory tract infection	5.5% 12/218 • Number of events 16 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	7.4% 16/215 • Number of events 18 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Infections and infestations Urinary tract infection	5.0% 11/218 • Number of events 12 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	2.3% 5/215 • Number of events 5 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Investigations Blood cholesterol increased	2.8% 6/218 • Number of events 6 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	5.1% 11/215 • Number of events 11 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Investigations Gamma-glutamyltransferase increased	0.92% 2/218 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	5.1% 11/215 • Number of events 11 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Investigations White blood cell count decreased	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	5.1% 11/215 • Number of events 14 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Dizziness	15.1% 33/218 • Number of events 48 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	8.4% 18/215 • Number of events 29 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Somnolence	9.2% 20/218 • Number of events 25 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	3.3% 7/215 • Number of events 8 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Headache	8.7% 19/218 • Number of events 33 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	7.4% 16/215 • Number of events 47 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.

Additional Information

UCB (Study Director)

UCB Cares

Phone: +1 887 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Levetiracetam (Safety Set) n=218 participants at risk During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.	Carbamazepine-IR (Safety Set) n=215 participants at risk During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
General disorders Peripheral swelling	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Infections and infestations Lung infection	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Brain contusion	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Burns third degree	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Epidural haemorrhage	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Hand fracture	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Overdose	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Status epilepticus	0.92% 2/218 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Epilepsy	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Seizure	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Subarachnoid haemorrhage	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Nervous system disorders Memory impairment	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Reproductive system and breast disorders Menopausal symptoms	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.00% 0/215 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Skin and subcutaneous tissue disorders Rash	0.00% 0/218 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.47% 1/215 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
Surgical and medical procedures Abortion induced	0.46% 1/218 • Number of events 1 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.	0.93% 2/215 • Number of events 2 • Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35). Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.