Trial Outcomes & Findings for An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy (NCT NCT01506882)

Last Updated: 2015-12-31

Results Overview

A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free: * A documented seizure during 6 consecutive months of the Evaluation Analysis Period * Subject discontinued the study prematurely during the Evaluation Analysis Period * Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

71 participants

Primary outcome timeframe

From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Results posted on

2015-12-31

Participant Flow

This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan.

Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups.

Participant milestones

Participant milestones
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily	Levetiracetam 3000 mg/Day Group * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. * Frequency: Twice daily
Overall Study STARTED	61	10
Overall Study COMPLETED	39	3
Overall Study NOT COMPLETED	22	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily	Levetiracetam 3000 mg/Day Group * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. * Frequency: Twice daily
Overall Study Lack of Efficacy	4	3
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	9	3
Overall Study SAE, non-fatal	2	0
Overall Study AE, non-serious non-fatal	3	1
Overall Study SAE,non-fatal+AE,non-serious non-fatal	1	0
Overall Study Other Reason	2	0

Baseline Characteristics

An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily	Levetiracetam 3000 mg/Day Group n=10 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. * Frequency: Twice daily	Total Title n=71 Participants
Age, Categorical <=18 years	10 Participants n=93 Participants	1 Participants n=4 Participants	11 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants	8 Participants n=4 Participants	53 Participants n=27 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants
Age, Continuous	36.5 years STANDARD_DEVIATION 18.0 • n=93 Participants	37.0 years STANDARD_DEVIATION 18.6 • n=4 Participants	36.5 years STANDARD_DEVIATION 17.9 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	4 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	6 Participants n=4 Participants	33 Participants n=27 Participants
Region of Enrollment Japan	61 participants n=93 Participants	10 participants n=4 Participants	71 participants n=27 Participants
Weight	58.98 kilogram (kg) STANDARD_DEVIATION 12.30 • n=93 Participants	62.58 kilogram (kg) STANDARD_DEVIATION 15.11 • n=4 Participants	59.48 kilogram (kg) STANDARD_DEVIATION 12.67 • n=27 Participants
Height	161.96 centimeter (cm) STANDARD_DEVIATION 8.77 • n=93 Participants	166.07 centimeter (cm) STANDARD_DEVIATION 10.21 • n=4 Participants	162.54 centimeter (cm) STANDARD_DEVIATION 9.02 • n=27 Participants

PRIMARY outcome

Timeframe: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Population: Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period	73.8 percentage of participants Interval 60.9 to 84.2

SECONDARY outcome

Timeframe: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

Population: Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.

Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period	59.0 percentage of participants Interval 45.7 to 71.4

SECONDARY outcome

Timeframe: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period

Population: Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=9 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period	22.2 percentage of participants Interval 2.8 to 60.0

SECONDARY outcome

Timeframe: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period

Population: Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.

Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=9 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period	11.1 percentage of participants Interval 0.3 to 48.2

SECONDARY outcome

Timeframe: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group	NA days Interval 359.0 to values not estimable due to small number of events

SECONDARY outcome

Timeframe: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

Median time to withdrawal will be estimated from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group	NA days values not estimable due to small number of events

SECONDARY outcome

Timeframe: During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year

Population: Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.

Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=9 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group	106 days Interval 9.0 to value not estimable due to small number of events

SECONDARY outcome

Timeframe: During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year

Population: Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.

Median time to withdrawal will be estimated from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=9 Participants * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group	91 days Interval 21.0 to 197.0

Adverse Events

Levetiracetam 1000 mg/Day to 2000 mg/Day Group

Serious events: 8 serious events

Other events: 58 other events

Deaths: 0 deaths

Levetiracetam 3000 mg/Day Group

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Levetiracetam 1000 mg/Day to 2000 mg/Day Group n=61 participants at risk * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. * Frequency: Twice daily	Levetiracetam 3000 mg/Day Group n=10 participants at risk * Formulation: Tablet * Strength: LEV 250 mg, LEV 500 mg * Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. * Frequency: Twice daily
General disorders Irritability	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Immune system disorders Anaphylactic reaction	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Infections and infestations Cystitis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Infections and infestations Kaposi's varicelliform eruption	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Infections and infestations Pyelonephritis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Nervous system disorders Status epilepticus	4.9% 3/61 • Number of events 3 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Nervous system disorders Postictal state	3.3% 2/61 • Number of events 2 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Nervous system disorders Convulsion	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Nervous system disorders Epilepsy	0.00% 0/61 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	10.0% 1/10 • Number of events 2 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Nervous system disorders Syncope	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Psychiatric disorders Agitation	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Psychiatric disorders Alcohol withdrawal syndrome	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Psychiatric disorders Postictal psychosis	1.6% 1/61 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Psychiatric disorders Suicide attempt	1.6% 1/61 • Number of events 2 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	0.00% 0/10 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
Surgical and medical procedures Meniscus removal	0.00% 0/61 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.	10.0% 1/10 • Number of events 1 • Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit. Adverse Events refer to the Safety Set, which includes all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.