Trial Outcomes & Findings for Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures (NCT NCT00771927)

NCT ID: NCT00771927

Last Updated: 2014-10-27

Results Overview

Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.

Recruitment status

COMPLETED

Target enrollment

1005 participants

Primary outcome timeframe

From Baseline up to 12 months

Results posted on

2014-10-27

Participant Flow

Patients were enrolled into 1 of 2 groups in this study (500 unique patients per group) at the discretion of the treating physician: patients treated with Vimpat as add-on to their current Anti-Epileptic Drug (AED) therapy (group 1) and patients treated with other approved AEDs as add-on (group 2).

Patient procedures and assessments were performed in the frame of the current standard practice at the discretion of the treating physician. Each patient was followed for the initial 12 months of add-on AED treatment. A Safety Follow-Up Visit is recommended for any patient who terminates add-on AED treatment before the end of the study period.

Participant milestones

Participant milestones
Measure	Lacosamide Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
Overall Study STARTED	511	493
Overall Study COMPLETED	256	256
Overall Study NOT COMPLETED	255	237

Reasons for withdrawal

Reasons for withdrawal
Measure	Lacosamide Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
Overall Study Adverse Event	100	105
Overall Study Lack of Efficacy	70	42
Overall Study Lost to Follow-up	46	46
Overall Study Withdrawal by Subject	16	17
Overall Study Other reason	23	27

Baseline Characteristics

Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lacosamide n=511 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED n=493 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy	Total n=1004 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	467 Participants n=5 Participants	434 Participants n=7 Participants	901 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	45 Participants n=7 Participants	69 Participants n=5 Participants
Age, Continuous	39.8 years STANDARD_DEVIATION 13.58 • n=5 Participants	42.3 years STANDARD_DEVIATION 15.38 • n=7 Participants	41.0 years STANDARD_DEVIATION 14.54 • n=5 Participants
Sex: Female, Male Female	266 Participants n=5 Participants	282 Participants n=7 Participants	548 Participants n=5 Participants
Sex: Female, Male Male	245 Participants n=5 Participants	211 Participants n=7 Participants	456 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	481 Participants n=5 Participants	464 Participants n=7 Participants	945 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Weight	75.5 kilogram STANDARD_DEVIATION 18.10 • n=5 Participants	75.7 kilogram STANDARD_DEVIATION 17.68 • n=7 Participants	75.6 kilogram STANDARD_DEVIATION 17.89 • n=5 Participants
Height	170.4 centimeter STANDARD_DEVIATION 10.97 • n=5 Participants	169.5 centimeter STANDARD_DEVIATION 9.24 • n=7 Participants	170.0 centimeter STANDARD_DEVIATION 10.18 • n=5 Participants
Body Mass Index (BMI)	26.0 kilogram per square meter STANDARD_DEVIATION 5.89 • n=5 Participants	26.2 kilogram per square meter STANDARD_DEVIATION 5.25 • n=7 Participants	26.1 kilogram per square meter STANDARD_DEVIATION 5.59 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to 12 months

Population: Safety Set (SS) population

Outcome measures

Outcome measures
Measure	Lacosamide n=511 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED n=493 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study	4 Treatment-Emergent Adverse Events	3 Treatment-Emergent Adverse Events

SECONDARY outcome

Timeframe: From Baseline up to 12 months

Population: Safety Set (SS) population

Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.

Outcome measures

Outcome measures
Measure	Lacosamide n=511 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED n=493 Participants Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study	22 Treatment-Emergent Adverse Events	31 Treatment-Emergent Adverse Events

Adverse Events

Lacosamide

Serious events: 78 serious events

Other events: 359 other events

Deaths: 0 deaths

Other AED

Serious events: 64 serious events

Other events: 299 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

Serious adverse events
Measure	Lacosamide n=511 participants at risk Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED n=493 participants at risk Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
Blood and lymphatic system disorders Leukopenia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.41% 2/493 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Atrial Flutter	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Atrial Fibrillation	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Palpitations	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Tachycardia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Left Ventricular Failure	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Congenital, familial and genetic disorders Foetal Malformation	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Vertigo	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Sudden Hearing Loss	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Diplopia	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Gastrointestinal disorders Nausea	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Gastrointestinal disorders Abdominal Pain Upper	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Gastrointestinal disorders Umbilical Hernia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Gastrointestinal disorders Vomiting	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Gastrointestinal disorders Anorectal Disorder	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Cyst Rupture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Drug Ineffective	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Gait Disturbance	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Idiosyncratic Drug Reaction	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Pyrexia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Sudden Unexplained Death in Epilepsy	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Death	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
General disorders Fatigue	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Furuncle	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Infection	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Bronchopneumonia	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Gastroenteritis	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Gastrointestinal Infection	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Infections and infestations Respiratory Tract Infection	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Fall	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Brain Contusion	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Contusion	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Facial Bones Fracture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Femur Fracture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Foot Fracture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Jaw Fracture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Rib Fracture	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Injury, poisoning and procedural complications Thermal Burn	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.

Other adverse events
Measure	Lacosamide n=511 participants at risk Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat	Other AED n=493 participants at risk Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
Psychiatric disorders Reading Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Anaemia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.61% 3/493 • Number of events 3 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Leukocytosis	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Thrombocytopenia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Leukopenia	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Blood and lymphatic system disorders Neutropenia	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Angina Pectoris	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Bundle Branch Block Right	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Sinus Bradycardia	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Ventricular Exrasystoles	0.39% 2/511 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Atrioventricular Block First Degree	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Bradycardia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.61% 3/493 • Number of events 3 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Conduction Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Palpitations	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Sinus Tachycardia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Supraventricular Extrasystoles	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.41% 2/493 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Atrial Fibrillation	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Bundle Branch Block Left	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Cardiac disorders Tachycardia	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Congenital, familial and genetic disorders Arteriovenous Malformation	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Vertigo	8.6% 44/511 • Number of events 49 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	2.2% 11/493 • Number of events 12 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Eustachian Tube Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Tinnitus	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Vestibular Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders External Ear Inflammation	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Ear and labyrinth disorders Hypoacusis	0.00% 0/511 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Endocrine disorders Hyperthyroidism	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Diplopia	10.2% 52/511 • Number of events 61 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	3.7% 18/493 • Number of events 19 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Vision Blurred	3.5% 18/511 • Number of events 18 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	2.6% 13/493 • Number of events 13 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Visual Impairment	1.8% 9/511 • Number of events 9 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.41% 2/493 • Number of events 2 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Accomodation Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Blepharospasm	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Conjunctival Hyperaemia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Excessive Eye Blinking	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Eye Disorder	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Eye Haemorrhage	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Eye Pain	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.20% 1/493 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Eye Swelling	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Ocular Discomfort	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.
Eye disorders Oscillopsia	0.20% 1/511 • Number of events 1 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.	0.00% 0/493 • Adverse Events were collected during the whole study from Baseline (Month 0) up to Visit 5 (Month 12). Adverse Events refer to the Safety Set (SS). SS includes all patients who have signed a data consent form, provided Baseline characteristic data, and received treatment at least once.