Trial Outcomes & Findings for Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy. (NCT NCT00546351)
NCT ID: NCT00546351
Last Updated: 2023-09-21
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
621 participants
Primary outcome timeframe
From entry Visit 1 through end of treatment (approximately 6.5 years)
Results posted on
2023-09-21
Participant Flow
The study started in May 2004 with subjects from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, and United Kingdom. The primary completion date occurred in January 2011, with study completion in January 2011.
Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
Participant milestones
| Measure |
Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Overall Study
STARTED
|
621
|
|
Overall Study
COMPLETED
|
385
|
|
Overall Study
NOT COMPLETED
|
236
|
Reasons for withdrawal
| Measure |
Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Overall Study
Adverse Event
|
76
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Withdrawal by Subject
|
109
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Protocol Deviation
|
1
|
|
Overall Study
Unsatisfactory compliance
|
9
|
|
Overall Study
Other reasons for premature termination
|
17
|
Baseline Characteristics
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Baseline characteristics by cohort
| Measure |
Lacosamide
n=621 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
500 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
121 Participants
n=93 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.51 • n=93 Participants
|
|
Sex: Female, Male
Female
|
296 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=93 Participants
|
|
Region of Enrollment
Serbia
|
54 participants
n=93 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=93 Participants
|
|
Region of Enrollment
Russian Federation
|
30 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=93 Participants
|
|
Region of Enrollment
France
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Czech Republic
|
57 participants
n=93 Participants
|
|
Region of Enrollment
Hungary
|
76 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
19 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
101 participants
n=93 Participants
|
|
Region of Enrollment
Romania
|
61 participants
n=93 Participants
|
|
Region of Enrollment
Bulgaria
|
62 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
117 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From entry Visit 1 through end of treatment (approximately 6.5 years)Population: This analysis includes all subjects (all 621) in the Safety Set (SS).
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=621 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
|
416 participants
|
PRIMARY outcome
Timeframe: From entry Visit 1 through end of treatment (approximately 6.5 years)Population: This analysis includes all subjects (all 621) in the Safety Set (SS).
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Is fatal * Is life-threatening * Results in persistent or significant disability/incapacity * Requires inpatient hospitalization * Prolongs existing inpatient hospitalization * Is a congenital anomaly/birth defect * Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Outcome measures
| Measure |
Lacosamide
n=621 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
|
132 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis. Data was not available for 1 subject at the time of this measurement.
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Outcome measures
| Measure |
Lacosamide
n=620 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
|
6.45 units on a scale
Standard Deviation 1.371
|
SECONDARY outcome
Timeframe: Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis. Data was not available for 2 subjects at the time of this measurement.
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Outcome measures
| Measure |
Lacosamide
n=619 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
|
3.01 units on a scale
Standard Deviation 2.246
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis. Data was not available for 408 subjects at the time of this measurement.
Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
Outcome measures
| Measure |
Lacosamide
n=213 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
|
65.83 units on a scale
Standard Deviation 15.986
|
SECONDARY outcome
Timeframe: Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis. Data was not available for 407 subjects at the time of this measurement.
On VAS 0 mm = no pain and 100 mm = worst possible pain.
Outcome measures
| Measure |
Lacosamide
n=214 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
|
30.47 units on a scale
Standard Deviation 23.940
|
SECONDARY outcome
Timeframe: Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis. Data was not available for 70 subjects at the time of this measurement.
The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse \[score of 1\] to much better \[score of 7\]). Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Outcome measures
| Measure |
Lacosamide
n=551 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Patient's Global Impression of Change (PGIC) at Last Visit.
Better
|
82.6 percentage of participants
|
|
Patient's Global Impression of Change (PGIC) at Last Visit.
No Change
|
11.4 percentage of participants
|
|
Patient's Global Impression of Change (PGIC) at Last Visit.
Worse
|
6.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = no pain and 10 = most intense pain sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
|
-3.2 units on a scale
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not sharp and 10 = most sharp sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
|
3.0 units on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not hot and 10 = the most hot sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
|
2.9 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not cold and 10 = the coldest sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
|
2.1 units on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not dull and 10 = most dull sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
|
2.9 units on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis. Data was not available for 428 subjects at the time of this measurement.
0 = not unpleasant and 10 = most unpleasant sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=193 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
|
3.8 units on a scale
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis. Data was not available for 428 subjects at the time of this measurement.
0 = no surface pain and 10 = most intense surface pain imaginable.
Outcome measures
| Measure |
Lacosamide
n=193 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
|
3.2 units on a scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis. Data was not available for 428 subjects at the time of this measurement.
0 = no deep pain and 10 = most intense deep pain imaginable.
Outcome measures
| Measure |
Lacosamide
n=193 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
|
3.4 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not itchy and 10 = most itchy sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
|
2.0 units on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline Visit; Last Visit (approximately 2 years)Population: Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis. Data was not available for 426 subjects at the time of this measurement.
0 = not sensitive and 10 = most sensitive sensation imaginable.
Outcome measures
| Measure |
Lacosamide
n=195 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
|
2.9 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis. Data was not available for 1 subject at the time of this measurement.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Outcome measures
| Measure |
Lacosamide
n=620 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
|
5.98 units on a scale
Standard Deviation 1.850
|
SECONDARY outcome
Timeframe: Last VisitPopulation: Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis. Data was not available for 2 subjects at the time of this measurement.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Outcome measures
| Measure |
Lacosamide
n=619 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
|
2.73 units on a scale
Standard Deviation 2.281
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis. Data was not available for 1 subject at the time of this measurement.
0 = no interference with activity and 10 = worst possible interference with activity.
Outcome measures
| Measure |
Lacosamide
n=620 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
|
6.11 units on a scale
Standard Deviation 1.660
|
SECONDARY outcome
Timeframe: Last VisitPopulation: Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis. Data was not available for 2 subjects at the time of this measurement.
0 = no interference with activity and 10 = worst possible interference with activity.
Outcome measures
| Measure |
Lacosamide
n=619 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
|
2.89 units on a scale
Standard Deviation 2.349
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis. Data was not available for 33 subjects at the time of this measurement.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Outcome measures
| Measure |
Lacosamide
n=588 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
|
32.8 units on a scale
Standard Deviation 8.04
|
SECONDARY outcome
Timeframe: Last VisitPopulation: Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis. Data was not available for 69 subjects at the time of this measurement.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Outcome measures
| Measure |
Lacosamide
n=552 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
|
38.4 units on a scale
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: BaselinePopulation: Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis. Data was not available for 33 subjects at the time of this measurement.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Outcome measures
| Measure |
Lacosamide
n=588 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
|
42.8 units on a scale
Standard Deviation 11.04
|
SECONDARY outcome
Timeframe: Last VisitPopulation: Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis. Data was not available for 69 subjects at the time of this measurement.
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Outcome measures
| Measure |
Lacosamide
n=552 Participants
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
|
44.5 units on a scale
Standard Deviation 10.90
|
Adverse Events
Lacosamide
Serious events: 132 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=621 participants at risk
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Angina pectoris
|
0.97%
6/621 • Number of events 6 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Coronary artery disease
|
0.81%
5/621 • Number of events 5 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
3/621 • Number of events 3 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Bundle branch block right
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Bundle branch block left
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Cardiac failure
|
0.32%
2/621 • Number of events 4 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Cardiac arrest
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Angina unstable
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Cardiogenic shock
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Endocrine disorders
Goitre
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Cataract
|
0.81%
5/621 • Number of events 5 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Retinal haemorrhage
|
0.16%
1/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Retinal detachment
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Blindness unilateral
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Vitreous haemorrhage
|
0.16%
1/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Eye disorders
Eye haemorrhage
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Gastroduodenitis haemorrhagic
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
General disorders
Pain
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
General disorders
Perforated ulcer
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
General disorders
Oedema peripheral
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Immune system disorders
Hypersensitivity
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Pyelonephritis acute
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Gangrene
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Superinfection
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Sepsis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Chronic sinusitis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Bronchitis fungal
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.16%
1/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Erysipelas
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Bronchopneumonia
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Bronchitis bacterial
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Appendicitis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Lung infection
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Localised infection
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Abscess limb
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Investigations
QRS axis abnormal
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.64%
4/621 • Number of events 4 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Gout
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
7/621 • Number of events 8 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.32%
2/621 • Number of events 12 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.16%
1/621 • Number of events 6 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Loss of consciousness
|
0.32%
2/621 • Number of events 3 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Presyncope
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Syncope
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Encephalopathy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Drop attacks
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Dizziness
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Paraesthesia
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Facial paresis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Apallic syndrome
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Brain stem syndrome
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Renal and urinary disorders
Renal colic
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Renal and urinary disorders
Proteinuria
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Renal and urinary disorders
Nephropathy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.48%
3/621 • Number of events 3 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.16%
1/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Surgical and medical procedures
Knee operation
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Surgical and medical procedures
Vitrectomy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Hypertension
|
0.64%
4/621 • Number of events 4 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Intermittent claudication
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Circulatory collapse
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
2/621 • Number of events 2 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Venous thrombosis limb
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Arterial haemorrhage
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Femoral artery occlusion
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Deep vein thrombosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Arterial stenosis limb
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Arterial stenosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Thrombosis
|
0.16%
1/621 • Number of events 1 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
Other adverse events
| Measure |
Lacosamide
n=621 participants at risk
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.5%
34/621 • Number of events 44 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
49/621 • Number of events 63 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
31/621 • Number of events 41 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Dizziness
|
7.2%
45/621 • Number of events 49 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Nervous system disorders
Headache
|
6.1%
38/621 • Number of events 45 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
|
Vascular disorders
Hypertension
|
6.4%
40/621 • Number of events 45 • Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
|
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