Trial Outcomes & Findings for Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1 (NCT NCT01406873)
NCT ID: NCT01406873
Last Updated: 2018-06-19
Results Overview
During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Mexiletine
This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
|
Placebo
This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Mexiletine
This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
|
Placebo
This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
Baseline characteristics by cohort
| Measure |
Mexiletine
n=21 Participants
This group received 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
|
Placebo
n=21 Participants
This group received 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
42.05 Years
STANDARD_DEVIATION 11.54 • n=39 Participants
|
38.14 Years
STANDARD_DEVIATION 9.78 • n=41 Participants
|
40.10 Years
STANDARD_DEVIATION 10.75 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment. Follow-up data was not collected on one participant in the mexiletine arm due to a broken foot.
During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.
Outcome measures
| Measure |
Mexiletine
n=19 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Mean Change From Baseline in Ambulation Using the 6 Minute Walk Distance
|
17.44 Meters
Standard Deviation 39.84
|
7.25 Meters
Standard Deviation 38.93
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.
Adverse events were monitored at the three in-person evaluations (Months 0, 3, and 6), at telephone evaluations every 2 weeks, and via patient-completed side effect diaries. The study investigators and safety monitoring committee reviewed adverse events and made decisions regarding drug withdrawals, suspensions, and dose reductions as needed.
Outcome measures
| Measure |
Mexiletine
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Percentage of Participants That Had a Dose Reduction or a Study Drug Withdrawal or Suspension Over 6 Months
Study Drug Withdrawal
|
2 Participants
|
0 Participants
|
|
Percentage of Participants That Had a Dose Reduction or a Study Drug Withdrawal or Suspension Over 6 Months
Study Drug Dose Reduction
|
1 Participants
|
0 Participants
|
|
Percentage of Participants That Had a Dose Reduction or a Study Drug Withdrawal or Suspension Over 6 Months
Study Drug Temporary Suspension
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication, and have post-baseline efficacy assessment at 6 months. Data was not analyzable on 3 people in the placebo arm.
Relaxation time of the long finger flexor muscles of the right hand after a maximum voluntary isometric contraction performed in a standardized fixed position of the right arm elbow/wrist/hand. Relaxation time for this measurement is defined as the time to relax from 90% to 5% of the maximum isometric force of contraction of the hand (the first of 6 serial contractions averaged over two consecutive trials performed 10 minutes apart).
Outcome measures
| Measure |
Mexiletine
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=17 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Mean Change From Baseline in Quantitative Measure of Hand Grip Myotonia
|
-1.01 Seconds
Standard Deviation 1.78
|
0.43 Seconds
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.
Manual muscle testing was performed on 26 muscle groups (shoulder abductors, elbow flexors, wrist flexors, wrist extensors, hip flexors, knee extensors, hip extensors, knee flexors, hip abductors, elbow extensors, ankle dorsiflexors, and plantar flexors on the right and left plus neck extensor and neck flexors). The muscles were tested in various positions including sitting, supine, prone, and side lying and each graded on a modification of the Medical Research Council (MRC) scale of 0 to 5 (5 representing normal strength). Average MMT score is derived by averaging the individual MMT scores across the 26 individual muscles.
Outcome measures
| Measure |
Mexiletine
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Mean Change From Baseline in Manual Muscle Testing (MMT) Score
|
0.05 Units on a scale
Standard Deviation 0.23
|
-0.06 Units on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsPopulation: Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.
PR, QRS, and QTc intervals as well as average minimum heart rate (HR) were obtained through standard 12 lead electrocardiograms (ECGs). Values were computer generated and verified by the study investigator and study cardiologist.
Outcome measures
| Measure |
Mexiletine
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring
PR Interval
|
11.35 Milliseconds
Standard Error 38.08
|
8.89 Milliseconds
Standard Error 13.20
|
|
Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring
QRS Interval
|
0.70 Milliseconds
Standard Error 11.50
|
1.00 Milliseconds
Standard Error 6.37
|
|
Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring
QTc Interval
|
-4.40 Milliseconds
Standard Error 23.37
|
-1.55 Milliseconds
Standard Error 14.75
|
|
Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring
Average Minimum Heart Rate
|
0.65 Milliseconds
Standard Error 4.57
|
-0.25 Milliseconds
Standard Error 5.72
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.
* The Myotonic Dystrophy Health Index (MDHI) is a validated disease-specific measure of patient-reported disease burden. The MDHI total score is a weighted average derived from 17 subscales. MDHI total scores range form 0-100 with 0 representing no patient-reported disease burden and 100 representing the most severe patient-reported disease burden. * The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a measure of quality of life in neuromuscular disease. The INQoL summary score is a weighted average made up of 5 sub-domains. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life with higher scores indicating more detrimental impact. * The 36-Item Short Form Survey (SF-36) is a generic measure of quality of life across 8 domains. Two summary metrics are produced from the 8 domains, ranging from 0-100% with lower scores representing worse levels of functioning.
Outcome measures
| Measure |
Mexiletine
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=20 Participants
Mean Change from Baseline in Ambulation using the 6 Minute Walk Test in Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life
INQoL
|
5.11 Units on a scale
Standard Deviation 14.80
|
2.33 Units on a scale
Standard Deviation 12.84
|
|
Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life
MDHI
|
0.01 Units on a scale
Standard Deviation 7.75
|
-1.10 Units on a scale
Standard Deviation 10.02
|
|
Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life
SF-36 Physical Component Summary
|
-1.73 Units on a scale
Standard Deviation 7.12
|
-1.35 Units on a scale
Standard Deviation 7.22
|
|
Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life
SF-36 Mental Component Summary
|
-0.62 Units on a scale
Standard Deviation 9.01
|
-0.79 Units on a scale
Standard Deviation 9.22
|
Adverse Events
Mexiletine
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mexiletine
n=21 participants at risk
Adverse Events for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=21 participants at risk
Adverse Events for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
Other adverse events
| Measure |
Mexiletine
n=21 participants at risk
Adverse Events for Patients who Received Mexiletine (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
Placebo
n=21 participants at risk
Adverse Events for Patients who Received Placebo (150 mg/kg capsules taken by mouth, three times daily for 6 months)
|
|---|---|---|
|
Gastrointestinal disorders
Esophageal pain
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, gastric distension
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Bloating
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
7/21 • Number of events 7 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Dysphagia
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Cardiac disorders
Cardiac disorders - Other, increased PVCs
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Cardiac disorders
Chest pain - cardiac
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Eye disorders
Blurred vision
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, viral gastroenteritis
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • Number of events 8 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
23.8%
5/21 • Number of events 5 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Stomach pain
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
General disorders
Fatigue
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
General disorders
Flu like symptoms
|
57.1%
12/21 • Number of events 21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
71.4%
15/21 • Number of events 28 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
General disorders
Pain
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, elevated GGT
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Infections and infestations
Bladder infection
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Infections and infestations
Infections and infestations - Other, elevated eosinophils
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Burn
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Fall
|
23.8%
5/21 • Number of events 7 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, cut finger
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, tendinitis
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, wrist sprain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, extreme thirst
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, heel spur
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, pelvic pain
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Dizziness
|
19.0%
4/21 • Number of events 4 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
19.0%
4/21 • Number of events 7 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Nervous system disorders - Other, idiopathic transient brain brainstem dysfuncti
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Nervous system disorders - Other, imbalance
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Nervous system disorders - Other, numbness
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Nervous system disorders - Other, transient lack of focus
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Presyncope
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Spasticity
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Nervous system disorders
Dysesthesia
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, bladder pain
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, endometriosis
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, ovarian cyst
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, uterine fibroid
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
19.0%
4/21 • Number of events 5 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, pneumonia
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, bumps on face
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hair thinning
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, rash
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, cataract surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, gum surgery
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, laser eye surgery
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, mole removal
|
4.8%
1/21 • Number of events 2 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, molluscum removal
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, root canal
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, tooth extraction
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, tubal ligation
|
0.00%
0/21 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected for 7 months. This period included 6 months (starting from randomization) on study drug (mexiletine vs. placebo) and 1 month post discontinuation of study drug.
2 subjects experienced study related AEs prior to randomization; both were in the mexiletine arm and both AEs were 'Skin and subcutaneous tissue disorders - Other, rash' and related to study procedures (where Holter monitor electrodes were placed). They are not included in the AE data displayed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place