Trial Outcomes & Findings for Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures (NCT NCT00515619)
NCT ID: NCT00515619
Last Updated: 2017-08-28
Results Overview
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
During the Treatment Period (up to 5.5 years)
Results posted on
2017-08-28
Participant Flow
The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.
Safety Set consists of all subjects who received at least 1 dose of Lacosamide.
Participant milestones
| Measure |
Lacosamide
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Overall Study
STARTED
|
376
|
|
Overall Study
Safety Set
|
376
|
|
Overall Study
COMPLETED
|
160
|
|
Overall Study
NOT COMPLETED
|
216
|
Reasons for withdrawal
| Measure |
Lacosamide
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Overall Study
Adverse Event
|
34
|
|
Overall Study
Lack of Efficacy
|
92
|
|
Overall Study
Withdrawal by Subject
|
66
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Unsatisfactory compliance
|
6
|
|
Overall Study
Other: Site discontinuing trials
|
2
|
|
Overall Study
Other: Subject cannot attend visits
|
2
|
|
Overall Study
Other: Subject required surgery
|
1
|
|
Overall Study
Other: Subject moved to another country
|
1
|
|
Overall Study
Other: Investigator decision
|
1
|
|
Overall Study
Other: Subject became pregnant
|
1
|
|
Overall Study
Other: Request from sponsor
|
1
|
|
Overall Study
Other: Drug available on license
|
1
|
|
Overall Study
Other: Subject interested in other AED
|
1
|
Baseline Characteristics
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
366 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
31 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 5.5 years)Population: Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
|
311 Subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 5.5 years)Population: Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
|
33 Subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 5.5 years)Population: Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Outcome measures
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
|
87 Subjects
|
SECONDARY outcome
Timeframe: Baseline, Treatment Period (up to 5.5 years)Population: Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Outcome measures
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
|
-49.9 Percentage change
Interval -100.0 to 422.8
|
SECONDARY outcome
Timeframe: Treatment Period (up to 5.5 years)Population: Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Outcome measures
| Measure |
Lacosamide
n=376 Participants
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
|
50.0 Percentage of subjects
|
Adverse Events
Lacosamide
Serious events: 87 serious events
Other events: 232 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=376 participants at risk
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Cardiac disorders
Cardiac arrest
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Congenital, familial and genetic disorders
Exomphalos
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Endocrine disorders
Hyperthyroidism
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Eye disorders
Diplopia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Eye disorders
Scotoma
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Eye disorders
Eye haemorrhage
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Gastrointestinal disorders
Anal fistula
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Gastrointestinal disorders
Haematemesis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
General disorders
Chest pain
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
General disorders
Chest discomfort
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Gastroenteritis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Abscess limb
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Appendicitis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Postoperative wound infection
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Intervertebral discitis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Sepsis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Pilonidal cyst
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Pneumonia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Head injury
|
0.80%
3/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.80%
3/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.80%
3/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.80%
3/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Contusion
|
0.27%
1/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Fall
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Investigations
Weight decreased
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Investigations
Investigation
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Convulsion
|
4.0%
15/376 • Number of events 21 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Epilepsy
|
1.9%
7/376 • Number of events 8 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Status epilepticus
|
1.3%
5/376 • Number of events 5 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Grand mal convulsion
|
0.80%
3/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Headache
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Hydrocephalus
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Coordination abnormal
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Monoparesis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Somnolence
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Cerebral haematoma
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Paresis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Sciatica
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Visual field defect
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Complex partial seizures
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Encephalitis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Aura
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Hemiparesis
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Intracranial pressure increased
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Simple partial seizures
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Depression
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Epileptic psychosis
|
0.53%
2/376 • Number of events 3 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Aggression
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Suicidal ideation
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Pathological gambling
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Confusional state
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Renal and urinary disorders
Calculus ureteric
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.53%
2/376 • Number of events 2 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Social circumstances
Breast prosthesis user
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Surgical and medical procedures
Shoulder operation
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Surgical and medical procedures
Knee meniscectomy
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Surgical and medical procedures
Hospitalisation
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Vascular disorders
Ischaemia
|
0.27%
1/376 • Number of events 1 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
Other adverse events
| Measure |
Lacosamide
n=376 participants at risk
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.2%
31/376 • Number of events 35 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Eye disorders
Diplopia
|
13.6%
51/376 • Number of events 63 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
25/376 • Number of events 33 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
General disorders
Fatigue
|
5.9%
22/376 • Number of events 25 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
52/376 • Number of events 77 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
20/376 • Number of events 29 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
28/376 • Number of events 38 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Dizziness
|
24.2%
91/376 • Number of events 157 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Headache
|
14.4%
54/376 • Number of events 97 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Somnolence
|
7.2%
27/376 • Number of events 34 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Tremor
|
6.1%
23/376 • Number of events 31 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Balance disorder
|
5.1%
19/376 • Number of events 25 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Nervous system disorders
Convulsion
|
5.1%
19/376 • Number of events 23 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
|
Psychiatric disorders
Depression
|
5.1%
19/376 • Number of events 20 • The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER