Trial Outcomes & Findings for A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy (NCT NCT00235443)
NCT ID: NCT00235443
Last Updated: 2018-07-17
Results Overview
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
451 participants
Primary outcome timeframe
Throughout the study up to a maximum study period of 2.8 years
Results posted on
2018-07-17
Participant Flow
Trial SP745 (NCT00235443) was conducted in 93 sites in the US and 89 of these sites screened at least 1 subject. The first subject was enrolled on 13Sep2004 and the last subject completed on 25Jul2008.
Participant milestones
| Measure |
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
57
|
85
|
205
|
39
|
54
|
|
Overall Study
COMPLETED
|
3
|
19
|
23
|
108
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
8
|
38
|
62
|
97
|
30
|
45
|
Reasons for withdrawal
| Measure |
Lacosamide 100mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
12
|
17
|
44
|
10
|
15
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
5
|
12
|
2
|
9
|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
25
|
24
|
10
|
12
|
|
Overall Study
Lost to Follow-up
|
0
|
8
|
6
|
6
|
4
|
3
|
|
Overall Study
Unsatisfactory compliance
|
0
|
2
|
3
|
4
|
1
|
0
|
|
Overall Study
Other reasons for premature termination
|
1
|
6
|
6
|
7
|
3
|
6
|
Baseline Characteristics
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=57 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=85 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=205 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=39 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=54 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
339 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
112 Participants
n=8 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 10.53 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 9.43 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 9.52 • n=21 Participants
|
55.5 years
STANDARD_DEVIATION 10.10 • n=8 Participants
|
58.1 years
STANDARD_DEVIATION 9.60 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
200 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
251 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
57 participants
n=7 Participants
|
85 participants
n=5 Participants
|
205 participants
n=4 Participants
|
39 participants
n=21 Participants
|
54 participants
n=8 Participants
|
451 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Throughout the study up to a maximum study period of 2.8 yearsPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=57 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=85 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=205 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=39 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=54 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=451 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
|
11 Participants
|
52 Participants
|
74 Participants
|
196 Participants
|
33 Participants
|
50 Participants
|
416 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of entire treatment phase (maximum study period of 2.8 years).Population: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=56 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=80 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=204 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=38 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=53 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=442 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
|
-5.15 Units on a scale
Standard Deviation 2.345
|
-4.30 Units on a scale
Standard Deviation 1.991
|
-3.70 Units on a scale
Standard Deviation 2.020
|
-3.29 Units on a scale
Standard Deviation 1.872
|
-3.54 Units on a scale
Standard Deviation 1.602
|
-2.73 Units on a scale
Standard Deviation 2.064
|
-3.49 Units on a scale
Standard Deviation 1.982
|
SECONDARY outcome
Timeframe: Baseline to end of entire treatment phase (maximum study period of 2.8 years).Population: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=57 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=81 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=205 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=39 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=54 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=447 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
|
-47.83 Units on a scale
Standard Deviation 34.022
|
-43.06 Units on a scale
Standard Deviation 23.901
|
-35.24 Units on a scale
Standard Deviation 26.837
|
-30.06 Units on a scale
Standard Deviation 23.723
|
-36.73 Units on a scale
Standard Deviation 18.025
|
-27.70 Units on a scale
Standard Deviation 22.427
|
-33.39 Units on a scale
Standard Deviation 24.484
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. 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 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=62 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=182 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=372 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Better
|
10 Participants
|
42 Participants
|
50 Participants
|
147 Participants
|
26 Participants
|
34 Participants
|
309 Participants
|
|
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
No Change
|
0 Participants
|
3 Participants
|
10 Participants
|
15 Participants
|
0 Participants
|
1 Participants
|
29 Participants
|
|
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Worse
|
1 Participants
|
0 Participants
|
2 Participants
|
20 Participants
|
4 Participants
|
7 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=62 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=370 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
|
-4.6 Units on a scale
Standard Deviation 2.63
|
-4.4 Units on a scale
Standard Deviation 3.03
|
-3.1 Units on a scale
Standard Deviation 2.86
|
-2.7 Units on a scale
Standard Deviation 2.96
|
-3.5 Units on a scale
Standard Deviation 2.22
|
-2.0 Units on a scale
Standard Deviation 2.61
|
-3.0 Units on a scale
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=62 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=370 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
|
-4.5 Units on a scale
Standard Deviation 2.76
|
-4.2 Units on a scale
Standard Deviation 3.07
|
-3.3 Units on a scale
Standard Deviation 3.25
|
-2.8 Units on a scale
Standard Deviation 3.20
|
-3.9 Units on a scale
Standard Deviation 2.51
|
-1.9 Units on a scale
Standard Deviation 3.00
|
-3.1 Units on a scale
Standard Deviation 3.17
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=62 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=370 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
|
-5.3 Units on a scale
Standard Deviation 3.74
|
-3.0 Units on a scale
Standard Deviation 3.65
|
-3.1 Units on a scale
Standard Deviation 3.44
|
-2.6 Units on a scale
Standard Deviation 3.14
|
-2.8 Units on a scale
Standard Deviation 2.58
|
-1.2 Units on a scale
Standard Deviation 2.86
|
-2.7 Units on a scale
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=62 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=370 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
|
-3.4 Units on a scale
Standard Deviation 2.41
|
-2.6 Units on a scale
Standard Deviation 3.03
|
-2.6 Units on a scale
Standard Deviation 2.88
|
-2.4 Units on a scale
Standard Deviation 3.34
|
-2.4 Units on a scale
Standard Deviation 3.65
|
-1.8 Units on a scale
Standard Deviation 3.23
|
-2.4 Units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=180 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=368 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
|
-1.6 Units on a scale
Standard Deviation 3.34
|
-1.9 Units on a scale
Standard Deviation 3.14
|
-1.2 Units on a scale
Standard Deviation 3.13
|
-1.7 Units on a scale
Standard Deviation 3.19
|
-2.2 Units on a scale
Standard Deviation 3.64
|
-0.5 Units on a scale
Standard Deviation 3.01
|
-1.5 Units on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=369 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
|
-2.8 Units on a scale
Standard Deviation 4.78
|
-3.4 Units on a scale
Standard Deviation 3.46
|
-1.8 Units on a scale
Standard Deviation 3.10
|
-2.1 Units on a scale
Standard Deviation 3.44
|
-2.7 Units on a scale
Standard Deviation 3.24
|
-1.4 Units on a scale
Standard Deviation 3.26
|
-2.2 Units on a scale
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=181 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=369 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
|
-2.2 Units on a scale
Standard Deviation 2.94
|
-2.0 Units on a scale
Standard Deviation 3.19
|
-1.4 Units on a scale
Standard Deviation 3.26
|
-1.1 Units on a scale
Standard Deviation 3.03
|
-2.1 Units on a scale
Standard Deviation 2.57
|
-0.5 Units on a scale
Standard Deviation 2.79
|
-1.3 Units on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=180 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=368 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
|
-5.0 Units on a scale
Standard Deviation 3.56
|
-4.0 Units on a scale
Standard Deviation 3.15
|
-3.3 Units on a scale
Standard Deviation 3.08
|
-2.9 Units on a scale
Standard Deviation 2.96
|
-3.3 Units on a scale
Standard Deviation 2.85
|
-1.5 Units on a scale
Standard Deviation 2.61
|
-3.0 Units on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=180 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=368 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
|
-4.5 Units on a scale
Standard Deviation 3.34
|
-3.3 Units on a scale
Standard Deviation 3.58
|
-3.2 Units on a scale
Standard Deviation 3.35
|
-2.7 Units on a scale
Standard Deviation 3.11
|
-3.3 Units on a scale
Standard Deviation 2.94
|
-1.5 Units on a scale
Standard Deviation 2.88
|
-2.8 Units on a scale
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=10 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=60 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=179 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=366 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
|
-3.5 Units on a scale
Standard Deviation 4.30
|
-3.3 Units on a scale
Standard Deviation 3.53
|
-3.3 Units on a scale
Standard Deviation 3.28
|
-2.6 Units on a scale
Standard Deviation 2.96
|
-2.7 Units on a scale
Standard Deviation 2.89
|
-1.5 Units on a scale
Standard Deviation 2.95
|
-2.7 Units on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Baseline to end of entire treatment phase visitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=56 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=80 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=203 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=38 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=53 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=441 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
|
-4.62 Units on a scale
Standard Deviation 2.950
|
-3.86 Units on a scale
Standard Deviation 2.050
|
-3.32 Units on a scale
Standard Deviation 2.077
|
-3.15 Units on a scale
Standard Deviation 2.150
|
-3.34 Units on a scale
Standard Deviation 1.852
|
-2.85 Units on a scale
Standard Deviation 2.427
|
-3.29 Units on a scale
Standard Deviation 2.173
|
SECONDARY outcome
Timeframe: Baseline to end of entire treatment phase visitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=56 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=80 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=203 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=38 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=53 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=441 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
|
-4.82 Units on a scale
Standard Deviation 2.927
|
-3.82 Units on a scale
Standard Deviation 2.185
|
-3.36 Units on a scale
Standard Deviation 2.163
|
-3.00 Units on a scale
Standard Deviation 2.038
|
-3.30 Units on a scale
Standard Deviation 1.808
|
-2.54 Units on a scale
Standard Deviation 2.261
|
-3.18 Units on a scale
Standard Deviation 2.147
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=179 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=368 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
|
3.3 Units on a scale
Standard Deviation 11.25
|
5.5 Units on a scale
Standard Deviation 10.50
|
5.1 Units on a scale
Standard Deviation 9.14
|
3.7 Units on a scale
Standard Deviation 8.80
|
3.5 Units on a scale
Standard Deviation 6.70
|
2.1 Units on a scale
Standard Deviation 8.56
|
4.0 Units on a scale
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: Baseline to Termination VisitPopulation: Safety population are subjects who took at least one dose of lacosamide (LCM).
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Outcome measures
| Measure |
Lacosamide 100mg/Day
n=11 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=45 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=61 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=179 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=30 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=42 Participants
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=368 Participants
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
|
-3.4 Units on a scale
Standard Deviation 10.66
|
-0.1 Units on a scale
Standard Deviation 12.60
|
0.7 Units on a scale
Standard Deviation 10.78
|
-1.1 Units on a scale
Standard Deviation 11.09
|
-3.7 Units on a scale
Standard Deviation 14.34
|
-0.4 Units on a scale
Standard Deviation 12.02
|
-0.9 Units on a scale
Standard Deviation 11.60
|
Adverse Events
Lacosamide 100mg/Day
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Lacosamide 200mg/Day
Serious events: 13 serious events
Other events: 47 other events
Deaths: 0 deaths
Lacosamide 300mg/Day
Serious events: 17 serious events
Other events: 68 other events
Deaths: 0 deaths
Lacosamide 400mg/Day
Serious events: 52 serious events
Other events: 183 other events
Deaths: 0 deaths
Lacosamide 500mg/Day
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
Lacosamide 600mg/Day
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
Total
Serious events: 100 serious events
Other events: 379 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide 100mg/Day
n=11 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=57 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=85 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=205 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=39 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=54 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=451 participants at risk
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.89%
4/451 • Number of events 4 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.6%
7/451 • Number of events 7 • 3 years, 10 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
1.5%
3/205 • Number of events 3 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Artioventricular block second degree
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
General disorders
Chest pain
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 2 • 3 years, 10 months
|
2.4%
5/205 • Number of events 5 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.8%
8/451 • Number of events 9 • 3 years, 10 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.89%
4/451 • Number of events 4 • 3 years, 10 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 2 • 3 years, 10 months
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Investigations
Hepatitis C antibody positive
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease mixed cellularity stage unspecified
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 2 • 3 years, 10 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
Other adverse events
| Measure |
Lacosamide 100mg/Day
n=11 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 200mg/Day
n=57 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 300mg/Day
n=85 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 400mg/Day
n=205 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 500mg/Day
n=39 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Lacosamide 600mg/Day
n=54 participants at risk
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
|
Total
n=451 participants at risk
All modal dose groups combined
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
4.7%
4/85 • Number of events 4 • 3 years, 10 months
|
4.9%
10/205 • Number of events 10 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
4.0%
18/451 • Number of events 18 • 3 years, 10 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 3 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.89%
4/451 • Number of events 5 • 3 years, 10 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 3 • 3 years, 10 months
|
2.4%
2/85 • Number of events 5 • 3 years, 10 months
|
3.9%
8/205 • Number of events 9 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
3.8%
17/451 • Number of events 21 • 3 years, 10 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
5.4%
11/205 • Number of events 12 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
3.8%
17/451 • Number of events 18 • 3 years, 10 months
|
|
Eye disorders
Cataract
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
1.5%
3/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.1%
5/451 • Number of events 7 • 3 years, 10 months
|
|
Eye disorders
Visual disturbance
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 2 • 3 years, 10 months
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
14.0%
8/57 • Number of events 10 • 3 years, 10 months
|
15.3%
13/85 • Number of events 21 • 3 years, 10 months
|
16.1%
33/205 • Number of events 37 • 3 years, 10 months
|
15.4%
6/39 • Number of events 6 • 3 years, 10 months
|
7.4%
4/54 • Number of events 5 • 3 years, 10 months
|
14.4%
65/451 • Number of events 80 • 3 years, 10 months
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
8.8%
5/57 • Number of events 6 • 3 years, 10 months
|
5.9%
5/85 • Number of events 5 • 3 years, 10 months
|
9.3%
19/205 • Number of events 25 • 3 years, 10 months
|
12.8%
5/39 • Number of events 5 • 3 years, 10 months
|
3.7%
2/54 • Number of events 4 • 3 years, 10 months
|
8.2%
37/451 • Number of events 46 • 3 years, 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 3 years, 10 months
|
8.8%
5/57 • Number of events 5 • 3 years, 10 months
|
4.7%
4/85 • Number of events 4 • 3 years, 10 months
|
5.9%
12/205 • Number of events 14 • 3 years, 10 months
|
7.7%
3/39 • Number of events 4 • 3 years, 10 months
|
3.7%
2/54 • Number of events 6 • 3 years, 10 months
|
5.8%
26/451 • Number of events 33 • 3 years, 10 months
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
3.5%
3/85 • Number of events 4 • 3 years, 10 months
|
3.4%
7/205 • Number of events 7 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
3.8%
17/451 • Number of events 19 • 3 years, 10 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 2 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
3.4%
7/205 • Number of events 7 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
3.1%
14/451 • Number of events 15 • 3 years, 10 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
2.4%
11/451 • Number of events 11 • 3 years, 10 months
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.8%
8/451 • Number of events 8 • 3 years, 10 months
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.44%
2/451 • Number of events 3 • 3 years, 10 months
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
15.8%
9/57 • Number of events 11 • 3 years, 10 months
|
9.4%
8/85 • Number of events 9 • 3 years, 10 months
|
10.2%
21/205 • Number of events 24 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
5.6%
3/54 • Number of events 5 • 3 years, 10 months
|
9.8%
44/451 • Number of events 54 • 3 years, 10 months
|
|
General disorders
Fatigue
|
27.3%
3/11 • Number of events 3 • 3 years, 10 months
|
10.5%
6/57 • Number of events 6 • 3 years, 10 months
|
9.4%
8/85 • Number of events 9 • 3 years, 10 months
|
10.7%
22/205 • Number of events 24 • 3 years, 10 months
|
7.7%
3/39 • Number of events 5 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
9.3%
42/451 • Number of events 47 • 3 years, 10 months
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
3.5%
3/85 • Number of events 5 • 3 years, 10 months
|
3.9%
8/205 • Number of events 8 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
9.3%
5/54 • Number of events 6 • 3 years, 10 months
|
4.2%
19/451 • Number of events 22 • 3 years, 10 months
|
|
General disorders
Pyrexia
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 3 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
2.4%
5/205 • Number of events 5 • 3 years, 10 months
|
7.7%
3/39 • Number of events 3 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
2.9%
13/451 • Number of events 13 • 3 years, 10 months
|
|
General disorders
Gait disturbance
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
2.4%
5/205 • Number of events 6 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.6%
7/451 • Number of events 8 • 3 years, 10 months
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
7.7%
3/39 • Number of events 3 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.3%
6/451 • Number of events 6 • 3 years, 10 months
|
|
General disorders
Asthenia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
General disorders
Irritability
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
17.5%
10/57 • Number of events 11 • 3 years, 10 months
|
16.5%
14/85 • Number of events 18 • 3 years, 10 months
|
13.7%
28/205 • Number of events 50 • 3 years, 10 months
|
20.5%
8/39 • Number of events 11 • 3 years, 10 months
|
22.2%
12/54 • Number of events 13 • 3 years, 10 months
|
16.2%
73/451 • Number of events 104 • 3 years, 10 months
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • Number of events 3 • 3 years, 10 months
|
5.3%
3/57 • Number of events 4 • 3 years, 10 months
|
3.5%
3/85 • Number of events 4 • 3 years, 10 months
|
12.2%
25/205 • Number of events 33 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
5.6%
3/54 • Number of events 6 • 3 years, 10 months
|
8.4%
38/451 • Number of events 52 • 3 years, 10 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 7 • 3 years, 10 months
|
7.1%
6/85 • Number of events 7 • 3 years, 10 months
|
9.3%
19/205 • Number of events 26 • 3 years, 10 months
|
7.7%
3/39 • Number of events 5 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
7.3%
33/451 • Number of events 47 • 3 years, 10 months
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 3 • 3 years, 10 months
|
8.8%
5/57 • Number of events 6 • 3 years, 10 months
|
8.2%
7/85 • Number of events 8 • 3 years, 10 months
|
5.9%
12/205 • Number of events 19 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
5.6%
3/54 • Number of events 5 • 3 years, 10 months
|
6.7%
30/451 • Number of events 44 • 3 years, 10 months
|
|
Infections and infestations
Bronchitis
|
27.3%
3/11 • Number of events 3 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
8.2%
7/85 • Number of events 8 • 3 years, 10 months
|
4.9%
10/205 • Number of events 14 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
5.8%
26/451 • Number of events 31 • 3 years, 10 months
|
|
Infections and infestations
Influenza
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
8.8%
5/57 • Number of events 5 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
7.3%
15/205 • Number of events 21 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
5.3%
24/451 • Number of events 30 • 3 years, 10 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.9%
6/205 • Number of events 10 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
2.2%
10/451 • Number of events 14 • 3 years, 10 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.4%
5/205 • Number of events 7 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
2.2%
10/451 • Number of events 12 • 3 years, 10 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 4 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
1.5%
3/205 • Number of events 5 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.3%
6/451 • Number of events 9 • 3 years, 10 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Infections and infestations
Laryngitis
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
1.5%
3/205 • Number of events 3 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Fall
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
7.0%
4/57 • Number of events 4 • 3 years, 10 months
|
4.7%
4/85 • Number of events 6 • 3 years, 10 months
|
6.8%
14/205 • Number of events 15 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
7.4%
4/54 • Number of events 4 • 3 years, 10 months
|
6.2%
28/451 • Number of events 31 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 4 • 3 years, 10 months
|
9.4%
8/85 • Number of events 12 • 3 years, 10 months
|
4.4%
9/205 • Number of events 11 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
5.3%
24/451 • Number of events 32 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.9%
6/205 • Number of events 6 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
2.0%
9/451 • Number of events 9 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
1.5%
3/205 • Number of events 3 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.8%
8/451 • Number of events 8 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.0%
4/205 • Number of events 5 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.6%
7/451 • Number of events 8 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Wound
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
1.5%
3/205 • Number of events 3 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.3%
6/451 • Number of events 6 • 3 years, 10 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
9.1%
1/11 • Number of events 2 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 2 • 3 years, 10 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 4 • 3 years, 10 months
|
3.5%
3/85 • Number of events 4 • 3 years, 10 months
|
4.9%
10/205 • Number of events 10 • 3 years, 10 months
|
5.1%
2/39 • Number of events 4 • 3 years, 10 months
|
5.6%
3/54 • Number of events 4 • 3 years, 10 months
|
4.7%
21/451 • Number of events 26 • 3 years, 10 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
7.1%
6/85 • Number of events 6 • 3 years, 10 months
|
2.4%
5/205 • Number of events 5 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 3 • 3 years, 10 months
|
3.1%
14/451 • Number of events 16 • 3 years, 10 months
|
|
Investigations
Weight increased
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
5.6%
3/54 • Number of events 4 • 3 years, 10 months
|
2.2%
10/451 • Number of events 11 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 3 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
3.9%
8/205 • Number of events 10 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
3.3%
15/451 • Number of events 17 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/11 • 3 years, 10 months
|
7.0%
4/57 • Number of events 4 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.0%
4/205 • Number of events 5 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
2.2%
10/451 • Number of events 11 • 3 years, 10 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
7.7%
3/39 • Number of events 3 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
1.8%
8/451 • Number of events 8 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 4 • 3 years, 10 months
|
9.4%
8/85 • Number of events 10 • 3 years, 10 months
|
12.2%
25/205 • Number of events 29 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
5.6%
3/54 • Number of events 4 • 3 years, 10 months
|
8.9%
40/451 • Number of events 49 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • 3 years, 10 months
|
8.8%
5/57 • Number of events 5 • 3 years, 10 months
|
7.1%
6/85 • Number of events 7 • 3 years, 10 months
|
9.3%
19/205 • Number of events 26 • 3 years, 10 months
|
2.6%
1/39 • Number of events 3 • 3 years, 10 months
|
9.3%
5/54 • Number of events 5 • 3 years, 10 months
|
8.0%
36/451 • Number of events 46 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 3 • 3 years, 10 months
|
3.5%
2/57 • Number of events 3 • 3 years, 10 months
|
8.2%
7/85 • Number of events 8 • 3 years, 10 months
|
9.3%
19/205 • Number of events 29 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
7.1%
32/451 • Number of events 46 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 3 • 3 years, 10 months
|
10.5%
6/57 • Number of events 6 • 3 years, 10 months
|
3.5%
3/85 • Number of events 4 • 3 years, 10 months
|
4.9%
10/205 • Number of events 12 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
5.1%
23/451 • Number of events 28 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
5.9%
12/205 • Number of events 13 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
3.5%
16/451 • Number of events 17 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
2.9%
6/205 • Number of events 7 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
2.2%
10/451 • Number of events 11 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.3%
6/451 • Number of events 6 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.3%
6/451 • Number of events 6 • 3 years, 10 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.3%
6/451 • Number of events 6 • 3 years, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
19.3%
11/57 • Number of events 15 • 3 years, 10 months
|
27.1%
23/85 • Number of events 31 • 3 years, 10 months
|
22.9%
47/205 • Number of events 59 • 3 years, 10 months
|
23.1%
9/39 • Number of events 13 • 3 years, 10 months
|
13.0%
7/54 • Number of events 7 • 3 years, 10 months
|
22.0%
99/451 • Number of events 127 • 3 years, 10 months
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
17.5%
10/57 • Number of events 10 • 3 years, 10 months
|
9.4%
8/85 • Number of events 15 • 3 years, 10 months
|
15.1%
31/205 • Number of events 37 • 3 years, 10 months
|
10.3%
4/39 • Number of events 4 • 3 years, 10 months
|
3.7%
2/54 • Number of events 3 • 3 years, 10 months
|
12.4%
56/451 • Number of events 70 • 3 years, 10 months
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
7.0%
4/57 • Number of events 5 • 3 years, 10 months
|
8.2%
7/85 • Number of events 8 • 3 years, 10 months
|
10.2%
21/205 • Number of events 30 • 3 years, 10 months
|
12.8%
5/39 • Number of events 6 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
8.4%
38/451 • Number of events 50 • 3 years, 10 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
8.2%
7/85 • Number of events 7 • 3 years, 10 months
|
10.2%
21/205 • Number of events 21 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
9.3%
5/54 • Number of events 5 • 3 years, 10 months
|
8.2%
37/451 • Number of events 38 • 3 years, 10 months
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
5.3%
3/57 • Number of events 3 • 3 years, 10 months
|
3.5%
3/85 • Number of events 4 • 3 years, 10 months
|
7.3%
15/205 • Number of events 23 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
7.4%
4/54 • Number of events 4 • 3 years, 10 months
|
6.2%
28/451 • Number of events 38 • 3 years, 10 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • 3 years, 10 months
|
7.0%
4/57 • Number of events 4 • 3 years, 10 months
|
7.1%
6/85 • Number of events 6 • 3 years, 10 months
|
6.8%
14/205 • Number of events 15 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
5.5%
25/451 • Number of events 26 • 3 years, 10 months
|
|
Nervous system disorders
Memory impairment
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
4.7%
4/85 • Number of events 4 • 3 years, 10 months
|
3.9%
8/205 • Number of events 8 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
4.0%
18/451 • Number of events 18 • 3 years, 10 months
|
|
Nervous system disorders
Pallanaesthesia
|
0.00%
0/11 • 3 years, 10 months
|
7.0%
4/57 • Number of events 4 • 3 years, 10 months
|
1.2%
1/85 • Number of events 2 • 3 years, 10 months
|
3.9%
8/205 • Number of events 11 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
3.7%
2/54 • Number of events 3 • 3 years, 10 months
|
3.5%
16/451 • Number of events 21 • 3 years, 10 months
|
|
Nervous system disorders
Amnesia
|
18.2%
2/11 • Number of events 2 • 3 years, 10 months
|
1.8%
1/57 • Number of events 2 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
5.4%
11/205 • Number of events 13 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
3.5%
16/451 • Number of events 19 • 3 years, 10 months
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 6 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
5.4%
11/205 • Number of events 17 • 3 years, 10 months
|
2.6%
1/39 • Number of events 3 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
3.1%
14/451 • Number of events 27 • 3 years, 10 months
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/11 • 3 years, 10 months
|
5.3%
3/57 • Number of events 4 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
2.4%
11/451 • Number of events 12 • 3 years, 10 months
|
|
Nervous system disorders
Disturbance in attention
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
2.0%
4/205 • Number of events 4 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
1.6%
7/451 • Number of events 7 • 3 years, 10 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
12.3%
7/57 • Number of events 7 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
3.4%
7/205 • Number of events 7 • 3 years, 10 months
|
10.3%
4/39 • Number of events 4 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
5.5%
25/451 • Number of events 25 • 3 years, 10 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
3.5%
3/85 • Number of events 3 • 3 years, 10 months
|
6.3%
13/205 • Number of events 15 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
4.2%
19/451 • Number of events 21 • 3 years, 10 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
2.0%
4/205 • Number of events 7 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
1.9%
1/54 • Number of events 1 • 3 years, 10 months
|
2.0%
9/451 • Number of events 12 • 3 years, 10 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
0.98%
2/205 • Number of events 2 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.1%
5/451 • Number of events 6 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
5.9%
5/85 • Number of events 8 • 3 years, 10 months
|
6.3%
13/205 • Number of events 13 • 3 years, 10 months
|
7.7%
3/39 • Number of events 3 • 3 years, 10 months
|
7.4%
4/54 • Number of events 5 • 3 years, 10 months
|
6.0%
27/451 • Number of events 31 • 3 years, 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
1.5%
3/205 • Number of events 3 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
1.1%
5/451 • Number of events 5 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
10.5%
6/57 • Number of events 9 • 3 years, 10 months
|
1.2%
1/85 • Number of events 1 • 3 years, 10 months
|
4.4%
9/205 • Number of events 11 • 3 years, 10 months
|
5.1%
2/39 • Number of events 3 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
4.2%
19/451 • Number of events 25 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
4.7%
4/85 • Number of events 5 • 3 years, 10 months
|
3.9%
8/205 • Number of events 9 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 3 • 3 years, 10 months
|
4.0%
18/451 • Number of events 20 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/11 • 3 years, 10 months
|
3.5%
2/57 • Number of events 4 • 3 years, 10 months
|
2.4%
2/85 • Number of events 2 • 3 years, 10 months
|
1.5%
3/205 • Number of events 5 • 3 years, 10 months
|
5.1%
2/39 • Number of events 2 • 3 years, 10 months
|
3.7%
2/54 • Number of events 2 • 3 years, 10 months
|
2.4%
11/451 • Number of events 15 • 3 years, 10 months
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
1.8%
1/57 • Number of events 1 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.49%
1/205 • Number of events 1 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.67%
3/451 • Number of events 3 • 3 years, 10 months
|
|
Surgical and medical procedures
Wound treatment
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Surgical and medical procedures
Peripheral nerve transposition
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
0.00%
0/57 • 3 years, 10 months
|
0.00%
0/85 • 3 years, 10 months
|
0.00%
0/205 • 3 years, 10 months
|
0.00%
0/39 • 3 years, 10 months
|
0.00%
0/54 • 3 years, 10 months
|
0.22%
1/451 • Number of events 1 • 3 years, 10 months
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • 3 years, 10 months
|
3.5%
2/57 • Number of events 2 • 3 years, 10 months
|
4.7%
4/85 • Number of events 7 • 3 years, 10 months
|
4.9%
10/205 • Number of events 11 • 3 years, 10 months
|
2.6%
1/39 • Number of events 1 • 3 years, 10 months
|
5.6%
3/54 • Number of events 4 • 3 years, 10 months
|
4.7%
21/451 • Number of events 26 • 3 years, 10 months
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER