Epilepsy
Conditions
Keywords
Partial Seizures, Epilepsy, RTG115097, Complex Partial Seizures, Anticonvulsant, Potassium Channels, Epilepsies, Partial
Brief summary
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.
Detailed description
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.
Interventions
DRUGRetigabine (INN), Ezogabine (USAN)
Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 for the treatment of partial-onset seizures * Patient is expected to benefit from participation in the study in the opinion of the Investigator.
Exclusion criteria
* Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or is experiencing an ongoing serious adverse event. * Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition. * Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Abnormal Results of Neurological Examination | Baseline and up to 122 months | A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed. |
| Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Baseline and up to 122 months | Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Baseline and up to 122 months | Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Baseline and up to 122 months | Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Total Protein | Baseline and up to 122 months | Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Baseline and up to 122 months | Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Hematocrit | Baseline and up to 122 months | Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Hemoglobin | Baseline and up to 122 months | The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | Baseline and up to 122 months | The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Urine Specific Gravity | Baseline and up to 122 months | Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Urine Potential of Hydrogen (pH) | Baseline and up to 122 months | Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | Baseline and up to 122 months | The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | Baseline and up to 122 months | AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x). |
| Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Baseline and up to 122 months | The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Percentage of Participants With Abnormal Results of Physical Examination | Baseline and up to 122 months | A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Up to 122 months | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after Retigabine dose in this study and on or before 30 days after the last Retigabine dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study. |
| Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.) | Up to 122 months | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment disc. up to 122 months have been presented. |
| Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Up to 122 months | Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Baseline and up to 122 months | Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Baseline and up to 122 months | Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Body Temperature | Baseline and up to 122 months | Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Body Weight | Baseline and up to 122 months | Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | Baseline and up to 122 months | A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Friedericia's formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | Up to 121 months | Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented. |
| Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Up to 121 months | Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented. |
| Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination | Up to 121 months | VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented. |
| Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination | Up to 121 months | The parameter assessed was decrease in confrontation visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented. |
| Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | 3 years and 10 months | The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. Only those participants available at the specified time points were analyzed. |
| Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | 3 years and 10 months | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. |
| Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | 3 years and 10 months | Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis. |
| Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | 3 years and 10 months | Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis. |
| Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment. | Baseline and up to 121 months | 28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as (\[28-day partial seizure frequency for the period of interest - Baseline 28-day partial seizure frequency\] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed. |
| Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment | Baseline and up to 121 months | A Responder was defined as a participant with \>=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented. |
| Number of Participants Who Were Seizure Free for Any 6 Continuous Months | Up to 6 continuous months within the 121 months period | Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented. |
| Number of Participants Who Were Seizure Free for Any 12 Continuous Months | Up to 12 continuous months within the 121 months period | Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented. |
| Percentage of Seizure Free Days | Up to 121 months | A seizure free day is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed. |
| Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | Up to 121 months | RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented.. |
Countries
Australia, Belgium, France, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, Ukraine, United Kingdom
Participant flow
Recruitment details
This was a multi-center, open-label, long-term, safety, tolerability and efficacy study involving 57 study sites in 13 countries (Australia, Belgium, France, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, Ukraine, the United Kingdom and the United States).
Pre-assignment details
A total of 376 adult epilepsy participants with partial-onset seizures who completed the parent study (VRX-RET-E22-302 \[NCT00235755\]) entered this open label extension (OLE) study.
Participants by arm
| Arm | Count |
|---|---|
| Retigabine Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months. | 376 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Primary Reporting Phase | Adverse Event | 101 | 0 |
| Primary Reporting Phase | ALT/AST levels above 5 times the ULN | 3 | 0 |
| Primary Reporting Phase | Change in participant medical condition | 3 | 0 |
| Primary Reporting Phase | Discontinuation of study | 1 | 0 |
| Primary Reporting Phase | Due to pigmentation risk concerns | 2 | 0 |
| Primary Reporting Phase | Failed to return | 8 | 0 |
| Primary Reporting Phase | Lack of Efficacy | 56 | 0 |
| Primary Reporting Phase | Ministry of Health decision | 25 | 0 |
| Primary Reporting Phase | Missing | 1 | 0 |
| Primary Reporting Phase | Ongoing SAE from parent study | 1 | 0 |
| Primary Reporting Phase | Other | 1 | 0 |
| Primary Reporting Phase | Participant Immigrated to New Zealand | 1 | 0 |
| Primary Reporting Phase | Participant passed away | 1 | 0 |
| Primary Reporting Phase | Participant request | 2 | 0 |
| Primary Reporting Phase | Participant request unrelated to study | 2 | 0 |
| Primary Reporting Phase | Participant retired the informed consent | 1 | 0 |
| Primary Reporting Phase | Persistent ALT/AST above 3 times the ULN | 3 | 0 |
| Primary Reporting Phase | Physician Decision | 2 | 0 |
| Primary Reporting Phase | Pregnancy | 3 | 0 |
| Primary Reporting Phase | Protocol Violation | 10 | 0 |
| Primary Reporting Phase | Request of the sponsor | 19 | 0 |
| Primary Reporting Phase | Termination of study at sponsor request | 3 | 0 |
| Primary Reporting Phase | Withdrawal by Subject | 97 | 0 |
| Safety Follow-up Continuation Phase | Adverse Event | 0 | 1 |
| Safety Follow-up Continuation Phase | Missing SFUCP disposition information | 0 | 5 |
| Safety Follow-up Continuation Phase | Study Closed/Terminated | 0 | 2 |
| Safety Follow-up Continuation Phase | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Retigabine |
|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 11.85 |
| Race/Ethnicity, Customized African-American (Black) | 3 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 360 Participants |
| Race/Ethnicity, Customized Unknown | 10 Participants |
| Sex: Female, Male Female | 195 Participants |
| Sex: Female, Male Male | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 376 |
| other Total, other adverse events | 239 / 376 |
| serious Total, serious adverse events | 78 / 376 |
Outcome results
Primary
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST)
Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 1 (Month 1), n=352 | -0.9 International units per liter | Standard Deviation 14.47 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 1a (Month 2), n=1 | -18.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 2 (Month 3), n=322 | -1.5 International units per liter | Standard Deviation 14.56 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 2a (Month 4), n=1 | 4.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 3 (Month 6), n=279 | -1.2 International units per liter | Standard Deviation 14.91 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 4 (Month 9), n=248 | -3.0 International units per liter | Standard Deviation 14.25 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 5 (Month 12), n=228 | -1.9 International units per liter | Standard Deviation 15.06 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 6 (Month 16), n=200 | -1.8 International units per liter | Standard Deviation 15.96 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 7 (Month 20), n=176 | -3.6 International units per liter | Standard Deviation 17.32 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 8 (Month 24), n=163 | -4.0 International units per liter | Standard Deviation 17.68 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 9 (Month 28), n=142 | -3.1 International units per liter | Standard Deviation 17.88 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 10 (Month 32), n=126 | -4.6 International units per liter | Standard Deviation 18.94 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 11 (Month 36), n=116 | -6.2 International units per liter | Standard Deviation 22.36 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 12 (Month 40), n=108 | -4.8 International units per liter | Standard Deviation 21.05 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 13 (Month 44), n=101 | -5.8 International units per liter | Standard Deviation 21.53 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 14 (Month 48), n=101 | -7.2 International units per liter | Standard Deviation 21.34 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 15 (Month 52), n=88 | -2.5 International units per liter | Standard Deviation 23.46 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 16 (Month 56), n=76 | -0.1 International units per liter | Standard Deviation 19.72 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 17 (Month 60), n=90 | -5.1 International units per liter | Standard Deviation 21.15 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 18 (Month 64), n=55 | -2.0 International units per liter | Standard Deviation 18.95 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 19 (Month 68), n=50 | -0.6 International units per liter | Standard Deviation 14.6 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 20 (Month 72), n=58 | 0.3 International units per liter | Standard Deviation 23.56 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 21 (Month 76), n=40 | 0.8 International units per liter | Standard Deviation 15.41 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 22 (Month 80), n=35 | 3.2 International units per liter | Standard Deviation 19.97 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 23 (Month 84), n=32 | 0.2 International units per liter | Standard Deviation 16.54 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 24 (Month 88), n=28 | -0.1 International units per liter | Standard Deviation 19.55 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 25 (Month 92), n=25 | 1.5 International units per liter | Standard Deviation 21.27 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 26 (Month 96), n=26 | 4.8 International units per liter | Standard Deviation 23.1 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 27 (Month 100), n=20 | 4.1 International units per liter | Standard Deviation 14.67 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 28 (Month 104), n=16 | 8.6 International units per liter | Standard Deviation 21.8 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 29 (Month 108), n=13 | 6.6 International units per liter | Standard Deviation 17.94 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 30 (Month 112), n=4 | 1.8 International units per liter | Standard Deviation 14.57 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 31 (Month 116), n=3 | 3.0 International units per liter | Standard Deviation 3.61 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Visit 32 (Month 120), n=1 | 1.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | Alk. Phos., Follow up, n=261 | -0.4 International units per liter | Standard Deviation 18.15 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 1 (Month 1), n=352 | 2.6 International units per liter | Standard Deviation 20.05 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 1a (Month 2), n=1 | -24.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 2 (Month 3), n=322 | 1.5 International units per liter | Standard Deviation 16.57 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 2a (Month 4), n=1 | 45.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 3 (Month 6), n=278 | 1.3 International units per liter | Standard Deviation 13.99 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 4 (Month 9), n=246 | -0.2 International units per liter | Standard Deviation 10.94 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 5 (Month 12), n=227 | 3.4 International units per liter | Standard Deviation 28.91 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 6 (Month 16), n=200 | 1.3 International units per liter | Standard Deviation 12.56 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 7 (Month 20), n=174 | 1.2 International units per liter | Standard Deviation 17.23 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 8 (Month 24), n=163 | 0.5 International units per liter | Standard Deviation 11.03 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 9 (Month 28), n=141 | 1.7 International units per liter | Standard Deviation 16.4 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 10 (Month 32), n=126 | 1.0 International units per liter | Standard Deviation 9.95 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 11 (Month 36), n=115 | 0.1 International units per liter | Standard Deviation 8.11 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 12 (Month 40), n=107 | 0.9 International units per liter | Standard Deviation 8.49 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 13 (Month 44), n=101 | 0.6 International units per liter | Standard Deviation 8.39 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 14 (Month 48), n=99 | 0.5 International units per liter | Standard Deviation 8.47 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 15 (Month 52), n=88 | 0.9 International units per liter | Standard Deviation 9.83 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 16 (Month 56), n=75 | 1.3 International units per liter | Standard Deviation 9.16 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 17 (Month 60), n=89 | 0.0 International units per liter | Standard Deviation 8.06 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 18 (Month 64), n=54 | -0.8 International units per liter | Standard Deviation 7.12 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 19 (Month 68), n=50 | -0.5 International units per liter | Standard Deviation 7.57 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 20 (Month 72), n=58 | 0.6 International units per liter | Standard Deviation 10.7 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 21 (Month 76), n=39 | 0.3 International units per liter | Standard Deviation 10.65 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 22 (Month 80), n=35 | 0.1 International units per liter | Standard Deviation 16.27 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 23 (Month 84), n=32 | -2.3 International units per liter | Standard Deviation 7.95 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 24 (Month 88), n=28 | -4.1 International units per liter | Standard Deviation 9.45 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 25 (Month 92), n=25 | -4.2 International units per liter | Standard Deviation 9.99 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 26 (Month 96), n=26 | -1.6 International units per liter | Standard Deviation 11.74 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 27 (Month 100), n=20 | -3.2 International units per liter | Standard Deviation 6.76 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 28 (Month 104), n=16 | -3.1 International units per liter | Standard Deviation 12.15 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 29 (Month 108), n=13 | -3.6 International units per liter | Standard Deviation 8.65 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 30 (Month 112), n=4 | -5.3 International units per liter | Standard Deviation 11.84 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 31 (Month 116), n=3 | 2.3 International units per liter | Standard Deviation 18.15 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Visit 32 (Month 120), n=1 | 1.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | ALT, Follow up, n=259 | 5.5 International units per liter | Standard Deviation 64.04 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 1 (Month 1), n=352 | 2.1 International units per liter | Standard Deviation 13 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 1a (Month 2), n=1 | -65.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 2 (Month 3), n=322 | 1.8 International units per liter | Standard Deviation 14.76 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 2a (Month 4), n=1 | 24.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 3 (Month 6), n=278 | 1.0 International units per liter | Standard Deviation 9.6 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 4 (Month 9), n=246 | 0.7 International units per liter | Standard Deviation 8.9 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 5 (Month 12), n=227 | 3.0 International units per liter | Standard Deviation 16.88 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 6 (Month 16), n=200 | 1.7 International units per liter | Standard Deviation 7.95 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 7 (Month 20), n=174 | 2.7 International units per liter | Standard Deviation 10.53 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 8 (Month 24), n=162 | 2.7 International units per liter | Standard Deviation 8.42 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 9 (Month 28), n=141 | 3.3 International units per liter | Standard Deviation 11.36 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 10 (Month 32), n=126 | 3.3 International units per liter | Standard Deviation 7.36 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 11 (Month 36), n=115 | 3.2 International units per liter | Standard Deviation 7.77 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 12 (Month 40), n=106 | 3.6 International units per liter | Standard Deviation 8.78 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 13 (Month 44), n=101 | 3.7 International units per liter | Standard Deviation 8.37 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 14 (Month 48), n=99 | 3.9 International units per liter | Standard Deviation 7.67 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 15 (Month 52), n=87 | 2.7 International units per liter | Standard Deviation 8.15 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 16 (Month 56), n=74 | 3.7 International units per liter | Standard Deviation 8.77 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 17 (Month 60), n=89 | 3.6 International units per liter | Standard Deviation 6.57 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 18 (Month 64), n=54 | 2.1 International units per liter | Standard Deviation 8.24 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 19 (Month 68), n=50 | 2.3 International units per liter | Standard Deviation 7.22 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 20 (Month 72), n=58 | 4.0 International units per liter | Standard Deviation 10.35 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 21 (Month 76), n=39 | 3.9 International units per liter | Standard Deviation 10.22 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 22 (Month 80), n=35 | 3.8 International units per liter | Standard Deviation 11.96 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 23 (Month 84), n=32 | 1.9 International units per liter | Standard Deviation 9.96 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 24 (Month 88), n=28 | 3.5 International units per liter | Standard Deviation 11.21 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 25 (Month 92), n=25 | 1.3 International units per liter | Standard Deviation 9.09 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 26 (Month 96), n=26 | 2.5 International units per liter | Standard Deviation 9.78 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 27 (Month 100), n=20 | 1.6 International units per liter | Standard Deviation 7.67 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 28 (Month 104), n=16 | 3.2 International units per liter | Standard Deviation 10.71 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 29 (Month 108), n=13 | 0.7 International units per liter | Standard Deviation 8.7 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 30 (Month 112), n=4 | -4.5 International units per liter | Standard Deviation 10.6 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 31 (Month 116), n=3 | 2.7 International units per liter | Standard Deviation 23.03 |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Visit 32 (Month 120), n=1 | 7.0 International units per liter | — |
| Retigabine | Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) | AST, Follow up, n=257 | 3.4 International units per liter | Standard Deviation 36.36 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC)
Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 1a (Month 2), n=64 | 0.013 10^9 cells per Liter | Standard Deviation 0.034 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 4a (Month 10), n=111 | 0.003 10^9 cells per Liter | Standard Deviation 0.0276 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 5 (Month 12), n=225 | 0.002 10^9 cells per Liter | Standard Deviation 0.0188 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 6 (Month 16), n=198 | 0.002 10^9 cells per Liter | Standard Deviation 0.0215 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 13 (Month 44), n=98 | 0.002 10^9 cells per Liter | Standard Deviation 0.0157 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 17 (Month 60), n=89 | 0.006 10^9 cells per Liter | Standard Deviation 0.0186 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 18 (Month 64), n=51 | 0.005 10^9 cells per Liter | Standard Deviation 0.0334 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 19 (Month 68), n=50 | 0.006 10^9 cells per Liter | Standard Deviation 0.0184 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 20 (Month 72), n=54 | 0.005 10^9 cells per Liter | Standard Deviation 0.0173 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 21 (Month 76), n=39 | 0.009 10^9 cells per Liter | Standard Deviation 0.0226 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 22 (Month 80), n=35 | 0.004 10^9 cells per Liter | Standard Deviation 0.014 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 23 (Month 84), n=32 | 0.009 10^9 cells per Liter | Standard Deviation 0.0178 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 24 (Month 88), n=27 | 0.004 10^9 cells per Liter | Standard Deviation 0.0189 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 25 (Month 92), n=25 | 0.013 10^9 cells per Liter | Standard Deviation 0.0281 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 29 (Month 108), n=13 | 0.005 10^9 cells per Liter | Standard Deviation 0.0156 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 30 (Month 112), n=4 | 0.003 10^9 cells per Liter | Standard Deviation 0.0171 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 31 (Month 116), n=3 | -0.003 10^9 cells per Liter | Standard Deviation 0.0153 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 32 (Month 120), n=1 | -0.020 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 1a (Month 2), n=64 | -0.018 10^9 cells per Liter | Standard Deviation 0.0982 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 2a (Month 4), n=82 | -0.002 10^9 cells per Liter | Standard Deviation 0.1274 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 4 (Month 9), n=239 | 0.001 10^9 cells per Liter | Standard Deviation 0.1148 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 4a (Month 10), n=111 | -0.003 10^9 cells per Liter | Standard Deviation 0.1126 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 6 (Month 16), n=198 | -0.012 10^9 cells per Liter | Standard Deviation 0.1015 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 8 (Month 24), n=159 | -0.007 10^9 cells per Liter | Standard Deviation 0.0989 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 9 (Month 28), n=139 | -0.013 10^9 cells per Liter | Standard Deviation 0.0972 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 10 (Month 32), n=125 | -0.007 10^9 cells per Liter | Standard Deviation 0.0997 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 11 (Month 36), n=112 | -0.004 10^9 cells per Liter | Standard Deviation 0.1042 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 12 (Month 40), n=108 | -0.006 10^9 cells per Liter | Standard Deviation 0.1044 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 13 (Month 44), n=98 | -0.007 10^9 cells per Liter | Standard Deviation 0.0962 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 15 (Month 52), n=88 | -0.008 10^9 cells per Liter | Standard Deviation 0.1115 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 17 (Month 60), n=88 | 0.009 10^9 cells per Liter | Standard Deviation 0.1214 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 22 (Month 80), n=35 | 0.000 10^9 cells per Liter | Standard Deviation 0.1352 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 28 (Month 104), n=16 | 0.041 10^9 cells per Liter | Standard Deviation 0.1509 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 1 (Month 1), n=345 | -0.127 10^9 cells per Liter | Standard Deviation 0.4854 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 3 (Month 6), n=273 | -0.124 10^9 cells per Liter | Standard Deviation 0.4476 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 3a (Month 8), n=97 | -0.104 10^9 cells per Liter | Standard Deviation 0.4733 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 4a (Month 10), n=111 | 0.007 10^9 cells per Liter | Standard Deviation 0.4505 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 6 (Month 16), n=198 | -0.130 10^9 cells per Liter | Standard Deviation 0.4605 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 20 (Month 72), n=54 | 0.000 10^9 cells per Liter | Standard Deviation 0.5129 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 21 (Month 76), n=39 | 0.113 10^9 cells per Liter | Standard Deviation 0.5493 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 23 (Month 84), n=32 | 0.166 10^9 cells per Liter | Standard Deviation 0.4766 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 24 (Month 88), n=27 | 0.133 10^9 cells per Liter | Standard Deviation 0.5958 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 31 (Month 116), n=3 | 0.367 10^9 cells per Liter | Standard Deviation 0.4038 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 4 (Month 9), n=239 | 0.022 10^9 cells per Liter | Standard Deviation 0.1518 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Follow up, n=252 | 0.022 10^9 cells per Liter | Standard Deviation 0.5031 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 2 (Month 3), n=309 | 0.017 10^9 cells per Liter | Standard Deviation 0.158 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 7 (Month 20), n=173 | 0.019 10^9 cells per Liter | Standard Deviation 0.1661 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 9 (Month 28), n=139 | 0.056 10^9 cells per Liter | Standard Deviation 0.1646 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 12 (Month 40), n=108 | 0.040 10^9 cells per Liter | Standard Deviation 0.175 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 18 (Month 64), n=51 | 0.028 10^9 cells per Liter | Standard Deviation 0.1644 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 21 (Month 76), n=39 | 0.078 10^9 cells per Liter | Standard Deviation 0.2002 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 25 (Month 92), n=25 | 0.057 10^9 cells per Liter | Standard Deviation 0.1956 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 28 (Month 104), n=16 | 0.039 10^9 cells per Liter | Standard Deviation 0.1903 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 3 (Month 6), n=273 | -0.087 10^9 cells per Liter | Standard Deviation 1.37 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 9 (Month 28), n=139 | 0.188 10^9 cells per Liter | Standard Deviation 1.2575 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 22 (Month 80), n=35 | 0.346 10^9 cells per Liter | Standard Deviation 1.3809 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 25 (Month 92), n=25 | 0.130 10^9 cells per Liter | Standard Deviation 1.9387 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Follow up, n=252 | 0.001 10^9 cells per Liter | Standard Deviation 0.0236 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 1 (Month 1), n=345 | -0.006 10^9 cells per Liter | Standard Deviation 0.1045 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 2 (Month 3), n=309 | -0.006 10^9 cells per Liter | Standard Deviation 0.1061 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 3 (Month 6), n=273 | -0.009 10^9 cells per Liter | Standard Deviation 0.0941 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 3a (Month 8), n=97 | -0.010 10^9 cells per Liter | Standard Deviation 0.1142 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 5 (Month 12), n=225 | -0.005 10^9 cells per Liter | Standard Deviation 0.116 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 7 (Month 20), n=173 | -0.008 10^9 cells per Liter | Standard Deviation 0.107 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 1 (Month 1), n=345 | 0.003 10^9 cells per Liter | Standard Deviation 0.0261 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 2 (Month 3), n=309 | 0.001 10^9 cells per Liter | Standard Deviation 0.0251 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 2a (Month 4), n=82 | 0.021 10^9 cells per Liter | Standard Deviation 0.0488 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 3 (Month 6), n=273 | 0.003 10^9 cells per Liter | Standard Deviation 0.034 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 3a (Month 8), n=97 | 0.005 10^9 cells per Liter | Standard Deviation 0.03 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 4 (Month 9), n=239 | 0.000 10^9 cells per Liter | Standard Deviation 0.0222 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 14 (Month 48), n=100 | -0.018 10^9 cells per Liter | Standard Deviation 0.0973 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 16 (Month 56), n=75 | -0.008 10^9 cells per Liter | Standard Deviation 0.1051 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 7 (Month 20), n=173 | 0.003 10^9 cells per Liter | Standard Deviation 0.023 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 8 (Month 24), n=159 | 0.001 10^9 cells per Liter | Standard Deviation 0.0205 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 9 (Month 28), n=139 | 0.005 10^9 cells per Liter | Standard Deviation 0.02 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 10 (Month 32), n=125 | 0.008 10^9 cells per Liter | Standard Deviation 0.0229 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 11 (Month 36), n=112 | 0.005 10^9 cells per Liter | Standard Deviation 0.02 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 12 (Month 40), n=108 | 0.007 10^9 cells per Liter | Standard Deviation 0.0253 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 14 (Month 48), n=100 | 0.002 10^9 cells per Liter | Standard Deviation 0.0201 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 15 (Month 52), n=88 | 0.005 10^9 cells per Liter | Standard Deviation 0.0249 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 16 (Month 56), n=75 | 0.006 10^9 cells per Liter | Standard Deviation 0.0245 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 26 (Month 96), n=24 | 0.010 10^9 cells per Liter | Standard Deviation 0.0254 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 27 (Month 100), n=20 | 0.010 10^9 cells per Liter | Standard Deviation 0.0192 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Basophils, Visit 28 (Month 104), n=16 | 0.008 10^9 cells per Liter | Standard Deviation 0.0118 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 18 (Month 64), n=51 | -0.001 10^9 cells per Liter | Standard Deviation 0.1298 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 19 (Month 68), n=50 | -0.008 10^9 cells per Liter | Standard Deviation 0.1335 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 20 (Month 72), n=54 | -0.002 10^9 cells per Liter | Standard Deviation 0.1235 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 21 (Month 76), n=39 | 0.000 10^9 cells per Liter | Standard Deviation 0.1365 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 23 (Month 84), n=32 | 0.015 10^9 cells per Liter | Standard Deviation 0.1251 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 24 (Month 88), n=27 | -0.022 10^9 cells per Liter | Standard Deviation 0.1272 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 25 (Month 92), n=25 | -0.004 10^9 cells per Liter | Standard Deviation 0.1064 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 26 (Month 96), n=24 | -0.007 10^9 cells per Liter | Standard Deviation 0.1082 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 27 (Month 100), n=20 | 0.032 10^9 cells per Liter | Standard Deviation 0.1637 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 29 (Month 108), n=13 | 0.062 10^9 cells per Liter | Standard Deviation 0.1678 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 30 (Month 112), n=4 | 0.185 10^9 cells per Liter | Standard Deviation 0.1933 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 31 (Month 116), n=3 | 0.043 10^9 cells per Liter | Standard Deviation 0.0603 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Visit 32 (Month 120), n=1 | -0.020 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Eosinophils, Follow up, n=252 | -0.010 10^9 cells per Liter | Standard Deviation 0.1082 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 1a (Month 2), n=64 | -0.029 10^9 cells per Liter | Standard Deviation 0.5459 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 2 (Month 3), n=309 | -0.147 10^9 cells per Liter | Standard Deviation 0.4446 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 2a (Month 4), n=82 | -0.089 10^9 cells per Liter | Standard Deviation 0.5561 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 4 (Month 9), n=239 | -0.137 10^9 cells per Liter | Standard Deviation 0.4833 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 5 (Month 12), n=225 | -0.118 10^9 cells per Liter | Standard Deviation 0.4839 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 7 (Month 20), n=173 | -0.103 10^9 cells per Liter | Standard Deviation 0.4656 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 8 (Month 24), n=159 | -0.091 10^9 cells per Liter | Standard Deviation 0.4387 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 9 (Month 28), n=139 | -0.099 10^9 cells per Liter | Standard Deviation 0.4582 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 10 (Month 32), n=125 | -0.103 10^9 cells per Liter | Standard Deviation 0.4502 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 11 (Month 36), n=112 | -0.135 10^9 cells per Liter | Standard Deviation 0.4232 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 12 (Month 40), n=108 | -0.114 10^9 cells per Liter | Standard Deviation 0.5521 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 13 (Month 44), n=98 | -0.057 10^9 cells per Liter | Standard Deviation 0.4896 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 14 (Month 48), n=100 | -0.117 10^9 cells per Liter | Standard Deviation 0.4672 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 15 (Month 52), n=88 | -0.055 10^9 cells per Liter | Standard Deviation 0.4918 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 16 (Month 56), n=75 | -0.049 10^9 cells per Liter | Standard Deviation 0.5077 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 17 (Month 60), n=88 | -0.034 10^9 cells per Liter | Standard Deviation 0.5568 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 18 (Month 64), n=51 | 0.004 10^9 cells per Liter | Standard Deviation 0.5778 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 19 (Month 68), n=50 | 0.077 10^9 cells per Liter | Standard Deviation 0.528 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 22 (Month 80), n=35 | 0.110 10^9 cells per Liter | Standard Deviation 0.5896 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 25 (Month 92), n=25 | 0.144 10^9 cells per Liter | Standard Deviation 0.394 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 26 (Month 96), n=24 | -0.001 10^9 cells per Liter | Standard Deviation 0.6195 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 27 (Month 100), n=20 | 0.172 10^9 cells per Liter | Standard Deviation 0.5272 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 28 (Month 104), n=16 | 0.141 10^9 cells per Liter | Standard Deviation 0.5226 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 29 (Month 108), n=13 | 0.193 10^9 cells per Liter | Standard Deviation 0.5144 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 30 (Month 112), n=4 | 0.278 10^9 cells per Liter | Standard Deviation 0.8945 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Lymphocytes, Visit 32 (Month 120), n=1 | -0.130 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 1 (Month 1), n=345 | 0.024 10^9 cells per Liter | Standard Deviation 0.1425 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 1a (Month 2), n=64 | 0.085 10^9 cells per Liter | Standard Deviation 0.1846 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 2a (Month 4), n=82 | 0.071 10^9 cells per Liter | Standard Deviation 0.185 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 3 (Month 6), n=273 | 0.022 10^9 cells per Liter | Standard Deviation 0.161 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 3a (Month 8), n=97 | 0.073 10^9 cells per Liter | Standard Deviation 0.1581 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 4a (Month 10), n=111 | 0.080 10^9 cells per Liter | Standard Deviation 0.1653 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 5 (Month 12), n=225 | 0.028 10^9 cells per Liter | Standard Deviation 0.1563 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 6 (Month 16), n=198 | 0.023 10^9 cells per Liter | Standard Deviation 0.1598 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 8 (Month 24), n=159 | 0.038 10^9 cells per Liter | Standard Deviation 0.184 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 10 (Month 32), n=125 | 0.047 10^9 cells per Liter | Standard Deviation 0.1597 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 11 (Month 36), n=112 | 0.049 10^9 cells per Liter | Standard Deviation 0.1649 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 13 (Month 44), n=98 | 0.037 10^9 cells per Liter | Standard Deviation 0.178 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 14 (Month 48), n=100 | 0.033 10^9 cells per Liter | Standard Deviation 0.1442 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 15 (Month 52), n=88 | 0.065 10^9 cells per Liter | Standard Deviation 0.172 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 16 (Month 56), n=75 | 0.043 10^9 cells per Liter | Standard Deviation 0.1632 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 17 (Month 60), n=88 | 0.044 10^9 cells per Liter | Standard Deviation 0.1736 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 19 (Month 68), n=50 | 0.027 10^9 cells per Liter | Standard Deviation 0.1253 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 20 (Month 72), n=54 | 0.039 10^9 cells per Liter | Standard Deviation 0.1201 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 22 (Month 80), n=35 | 0.046 10^9 cells per Liter | Standard Deviation 0.1629 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 23 (Month 84), n=32 | 0.064 10^9 cells per Liter | Standard Deviation 0.1596 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 24 (Month 88), n=27 | 0.065 10^9 cells per Liter | Standard Deviation 0.2083 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 26 (Month 96), n=24 | 0.035 10^9 cells per Liter | Standard Deviation 0.1405 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 27 (Month 100), n=20 | 0.119 10^9 cells per Liter | Standard Deviation 0.1604 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 29 (Month 108), n=13 | 0.068 10^9 cells per Liter | Standard Deviation 0.2342 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 30 (Month 112), n=4 | 0.030 10^9 cells per Liter | Standard Deviation 0.1985 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 31 (Month 116), n=3 | -0.007 10^9 cells per Liter | Standard Deviation 0.085 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Visit 32 (Month 120), n=1 | 0.080 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Monocytes, Follow up, n=252 | 0.022 10^9 cells per Liter | Standard Deviation 0.1754 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 1 (Month 1), n=345 | -0.143 10^9 cells per Liter | Standard Deviation 1.3093 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 1a (Month 2), n=64 | -0.142 10^9 cells per Liter | Standard Deviation 1.3123 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 2 (Month 3), n=309 | -0.045 10^9 cells per Liter | Standard Deviation 1.1768 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 2a (Month 4), n=82 | 0.075 10^9 cells per Liter | Standard Deviation 1.4826 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 3a (Month 8), n=97 | -0.098 10^9 cells per Liter | Standard Deviation 1.3412 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 4 (Month 9), n=239 | 0.032 10^9 cells per Liter | Standard Deviation 1.1933 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 4a (Month 10), n=111 | 0.203 10^9 cells per Liter | Standard Deviation 1.3922 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 5 (Month 12), n=225 | 0.015 10^9 cells per Liter | Standard Deviation 1.6014 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 6 (Month 16), n=198 | 0.086 10^9 cells per Liter | Standard Deviation 1.3107 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 7 (Month 20), n=173 | 0.121 10^9 cells per Liter | Standard Deviation 1.278 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 8 (Month 24), n=159 | 0.368 10^9 cells per Liter | Standard Deviation 1.4584 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 10 (Month 32), n=125 | 0.118 10^9 cells per Liter | Standard Deviation 1.1824 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 11 (Month 36), n=112 | 0.057 10^9 cells per Liter | Standard Deviation 1.2868 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 12 (Month 40), n=108 | 0.196 10^9 cells per Liter | Standard Deviation 1.177 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 13 (Month 44), n=98 | 0.243 10^9 cells per Liter | Standard Deviation 1.418 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 14 (Month 48), n=100 | 0.095 10^9 cells per Liter | Standard Deviation 1.241 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 15 (Month 52), n=88 | 0.432 10^9 cells per Liter | Standard Deviation 1.4504 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 16 (Month 56), n=75 | 0.412 10^9 cells per Liter | Standard Deviation 1.4045 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 17 (Month 60), n=88 | 0.416 10^9 cells per Liter | Standard Deviation 1.3905 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 18 (Month 64), n=51 | 0.296 10^9 cells per Liter | Standard Deviation 1.2674 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 19 (Month 68), n=50 | 0.436 10^9 cells per Liter | Standard Deviation 1.0379 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 20 (Month 72), n=54 | 0.552 10^9 cells per Liter | Standard Deviation 1.3322 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 21 (Month 76), n=39 | 0.639 10^9 cells per Liter | Standard Deviation 1.5548 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 23 (Month 84), n=32 | 0.560 10^9 cells per Liter | Standard Deviation 1.4536 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 24 (Month 88), n=27 | 0.366 10^9 cells per Liter | Standard Deviation 1.8672 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 26 (Month 96), n=24 | 0.707 10^9 cells per Liter | Standard Deviation 1.7085 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 27 (Month 100), n=20 | 0.247 10^9 cells per Liter | Standard Deviation 1.6045 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 28 (Month 104), n=16 | 0.458 10^9 cells per Liter | Standard Deviation 1.1406 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 29 (Month 108), n=13 | -0.027 10^9 cells per Liter | Standard Deviation 1.4607 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 30 (Month 112), n=4 | 0.658 10^9 cells per Liter | Standard Deviation 1.2219 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 31 (Month 116), n=3 | 0.297 10^9 cells per Liter | Standard Deviation 0.532 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Visit 32 (Month 120), n=1 | 0.470 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Neutrophils, Follow up, n=252 | -0.010 10^9 cells per Liter | Standard Deviation 1.5258 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet Count, Visit 1 (Month 1), n=345 | 0.9 10^9 cells per Liter | Standard Deviation 40.69 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 1a (Month 2), n=65 | 6.4 10^9 cells per Liter | Standard Deviation 41.67 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 2 (Month 3), n=311 | 0.7 10^9 cells per Liter | Standard Deviation 37.59 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 2a (Month 4), n=82 | 12.7 10^9 cells per Liter | Standard Deviation 37.26 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 3 (Month 6), n=273 | -1.7 10^9 cells per Liter | Standard Deviation 41.28 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 3a (Month 8), n=99 | -5.3 10^9 cells per Liter | Standard Deviation 31.49 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 4 (Month 9), n=241 | -7.1 10^9 cells per Liter | Standard Deviation 37.88 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 4a (Month 10), n=108 | -2.8 10^9 cells per Liter | Standard Deviation 38.71 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 5 (Month 12), n=225 | -8.6 10^9 cells per Liter | Standard Deviation 35.57 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 6 (Month 16), n=196 | -9.0 10^9 cells per Liter | Standard Deviation 43.09 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 7 (Month 20), n=171 | -15.8 10^9 cells per Liter | Standard Deviation 41.13 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 8 (Month 24), n=162 | -17.3 10^9 cells per Liter | Standard Deviation 44.99 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 9 (Month 28), n=137 | -18.0 10^9 cells per Liter | Standard Deviation 44.47 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 10 (Month 32), n=124 | -20.8 10^9 cells per Liter | Standard Deviation 38.96 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 11 (Month 36), n=114 | -25.8 10^9 cells per Liter | Standard Deviation 42.66 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 12 (Month 40), n=108 | -24.3 10^9 cells per Liter | Standard Deviation 39.96 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 13 (Month 44), n=98 | -22.4 10^9 cells per Liter | Standard Deviation 37.92 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 14 (Month 48), n=98 | -25.2 10^9 cells per Liter | Standard Deviation 37.88 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 15 (Month 52), n=84 | -22.3 10^9 cells per Liter | Standard Deviation 40.93 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 16 (Month 56), n=75 | -17.1 10^9 cells per Liter | Standard Deviation 50.19 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 17 (Month 60), n=88 | -18.6 10^9 cells per Liter | Standard Deviation 46.11 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 18 (Month 64), n=54 | -23.1 10^9 cells per Liter | Standard Deviation 38.78 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 19 (Month 68), n=50 | -17.7 10^9 cells per Liter | Standard Deviation 42.66 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 20 (Month 72), n=53 | -20.4 10^9 cells per Liter | Standard Deviation 51.9 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 21 (Month 76), n=40 | -11.1 10^9 cells per Liter | Standard Deviation 55.97 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 22 (Month 80), n=34 | -10.0 10^9 cells per Liter | Standard Deviation 57.22 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 23 (Month 84), n=31 | -7.0 10^9 cells per Liter | Standard Deviation 50.2 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 24 (Month 88), n=25 | -22.1 10^9 cells per Liter | Standard Deviation 29.77 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 25 (Month 92), n=25 | -16.8 10^9 cells per Liter | Standard Deviation 40.54 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 26 (Month 96), n=24 | -4.9 10^9 cells per Liter | Standard Deviation 43.76 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 27 (Month 100), n=20 | 1.9 10^9 cells per Liter | Standard Deviation 45.98 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 28 (Month 104), n=16 | -6.3 10^9 cells per Liter | Standard Deviation 44.81 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 29 (Month 108), n=13 | -9.5 10^9 cells per Liter | Standard Deviation 41.54 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 30 (Month 112), n=4 | 10.0 10^9 cells per Liter | Standard Deviation 32.44 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 31 (Month 116), n=3 | -5.7 10^9 cells per Liter | Standard Deviation 30.09 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Visit 32 (Month 120), n=1 | 25.0 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | Platelet count, Follow up, n=249 | -9.4 10^9 cells per Liter | Standard Deviation 49.63 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 1 (Month 1), n=349 | -0.25 10^9 cells per Liter | Standard Deviation 1.403 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 1a (Month 2), n=65 | -0.11 10^9 cells per Liter | Standard Deviation 1.478 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 2 (Month 3), n=315 | -0.22 10^9 cells per Liter | Standard Deviation 1.371 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 2a (Month 4), n=82 | 0.07 10^9 cells per Liter | Standard Deviation 1.648 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 3 (Month 6), n=278 | -0.20 10^9 cells per Liter | Standard Deviation 1.531 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 3a (Month 8), n=99 | -0.15 10^9 cells per Liter | Standard Deviation 1.537 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 4 (Month 9), n=244 | -0.08 10^9 cells per Liter | Standard Deviation 1.356 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 4a (Month 10), n=113 | 0.28 10^9 cells per Liter | Standard Deviation 1.608 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 5 (Month 12), n=226 | -0.09 10^9 cells per Liter | Standard Deviation 1.69 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 6 (Month 16), n=199 | -0.06 10^9 cells per Liter | Standard Deviation 1.385 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 7 (Month 20), n=174 | 0.01 10^9 cells per Liter | Standard Deviation 1.468 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 8 (Month 24), n=164 | 0.25 10^9 cells per Liter | Standard Deviation 1.655 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 9 (Month 28), n=142 | 0.10 10^9 cells per Liter | Standard Deviation 1.367 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 10 (Month 32), n=126 | 0.09 10^9 cells per Liter | Standard Deviation 1.374 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 11 (Month 36), n=115 | -0.05 10^9 cells per Liter | Standard Deviation 1.387 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 12 (Month 40), n=109 | 0.10 10^9 cells per Liter | Standard Deviation 1.514 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 13 (Month 44), n=98 | 0.21 10^9 cells per Liter | Standard Deviation 1.687 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 14 (Month 48), n=101 | -0.01 10^9 cells per Liter | Standard Deviation 1.381 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 15 (Month 52), n=88 | 0.43 10^9 cells per Liter | Standard Deviation 1.648 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 16 (Month 56), n=76 | 0.37 10^9 cells per Liter | Standard Deviation 1.603 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 17 (Month 60), n=89 | 0.41 10^9 cells per Liter | Standard Deviation 1.663 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 18 (Month 64), n=54 | 0.33 10^9 cells per Liter | Standard Deviation 1.613 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 19 (Month 68), n=50 | 0.54 10^9 cells per Liter | Standard Deviation 1.376 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 20 (Month 72), n=55 | 0.57 10^9 cells per Liter | Standard Deviation 1.532 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 21 (Month 76), n=40 | 0.81 10^9 cells per Liter | Standard Deviation 1.94 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 22 (Month 80), n=35 | 0.52 10^9 cells per Liter | Standard Deviation 1.622 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 23 (Month 84), n=32 | 0.83 10^9 cells per Liter | Standard Deviation 1.599 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 24 (Month 88), n=27 | 0.57 10^9 cells per Liter | Standard Deviation 1.964 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 25 (Month 92), n=25 | 0.34 10^9 cells per Liter | Standard Deviation 2.114 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 26 (Month 96), n=24 | 0.75 10^9 cells per Liter | Standard Deviation 1.67 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 27 (Month 100), n=20 | 0.59 10^9 cells per Liter | Standard Deviation 1.809 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 28 (Month 104), n=16 | 0.70 10^9 cells per Liter | Standard Deviation 1.372 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 29 (Month 108), n=13 | 0.30 10^9 cells per Liter | Standard Deviation 1.614 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 30 (Month 112), n=4 | 1.18 10^9 cells per Liter | Standard Deviation 1.864 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 31 (Month 116), n=3 | 0.70 10^9 cells per Liter | Standard Deviation 0.8 |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Visit 32 (Month 120), n=1 | 0.40 10^9 cells per Liter | — |
| Retigabine | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) | WBC, Follow up, n=255 | 0.02 10^9 cells per Liter | Standard Deviation 1.738 |
Primary
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea
Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 28 (Month 104), n=16 | 0.091 Millimoles per liter | Standard Deviation 0.1653 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 25 (Month 92), n=25 | -0.4 Millimoles per liter | Standard Deviation 5.97 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 28 (Month 104), n=16 | -1.1 Millimoles per liter | Standard Deviation 4.86 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 29 (Month 108), n=13 | -1.0 Millimoles per liter | Standard Deviation 5.66 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride,Visit 30 (Month 112), n=4 | -3.0 Millimoles per liter | Standard Deviation 4.24 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride,Visit 31 (Month 116), n=3 | -2.3 Millimoles per liter | Standard Deviation 5.03 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 32 (Month 120), n=1 | -3.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Follow up, n=261 | 0.3 Millimoles per liter | Standard Deviation 4.03 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 1 (Month 1), n=352 | 0.066 Millimoles per liter | Standard Deviation 0.6255 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 1a (Month 2), n=1 | -0.360 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 2a (Month 4), n=1 | -0.470 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 3 (Month 6), n=279 | 0.062 Millimoles per liter | Standard Deviation 0.6978 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 4 (Month 9), n=248 | 0.062 Millimoles per liter | Standard Deviation 0.7238 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 5 (Month 12), n=228 | 0.075 Millimoles per liter | Standard Deviation 0.7074 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 6 (Month 16), n=200 | 0.101 Millimoles per liter | Standard Deviation 0.7601 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 7 (Month 20), n=176 | 0.001 Millimoles per liter | Standard Deviation 0.782 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 8 (Month 24), n=163 | 0.087 Millimoles per liter | Standard Deviation 0.8471 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 9 (Month 28), n=142 | -0.001 Millimoles per liter | Standard Deviation 0.7732 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 10 (Month 32), n=126 | -0.028 Millimoles per liter | Standard Deviation 0.852 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 11 (Month 36), n=116 | -0.087 Millimoles per liter | Standard Deviation 0.7823 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 12 (Month 40), n=108 | -0.001 Millimoles per liter | Standard Deviation 0.783 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 13 (Month 44), n=101 | -0.043 Millimoles per liter | Standard Deviation 0.8053 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 14 (Month 48), n=101 | -0.128 Millimoles per liter | Standard Deviation 0.7505 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 15 (Month 52), n=88 | -0.057 Millimoles per liter | Standard Deviation 0.7427 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 16 (Month 56), n=76 | 0.026 Millimoles per liter | Standard Deviation 0.7354 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 17 (Month 60), n=90 | 0.016 Millimoles per liter | Standard Deviation 0.8209 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 18 (Month 64), n=55 | 0.054 Millimoles per liter | Standard Deviation 0.7474 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 19 (Month 68), n=50 | 0.074 Millimoles per liter | Standard Deviation 0.8943 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 20 (Month 72), n=58 | -0.048 Millimoles per liter | Standard Deviation 0.8221 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 21 (Month 76), n=40 | 0.103 Millimoles per liter | Standard Deviation 0.9056 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 22 (Month 80), n=35 | 0.096 Millimoles per liter | Standard Deviation 0.8671 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 25 (Month 92), n=25 | 0.327 Millimoles per liter | Standard Deviation 0.8143 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 26 (Month 96), n=26 | 0.489 Millimoles per liter | Standard Deviation 1.0353 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 27 (Month 100), n=20 | 0.370 Millimoles per liter | Standard Deviation 0.6675 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 28 (Month 104), n=16 | 0.354 Millimoles per liter | Standard Deviation 0.6488 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 29 (Month 108), n=13 | 0.141 Millimoles per liter | Standard Deviation 1.0346 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 30 (Month 112), n=4 | 1.775 Millimoles per liter | Standard Deviation 0.9858 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 31 (Month 116), n=3 | 1.123 Millimoles per liter | Standard Deviation 0.8723 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Follow up, n=261 | -0.070 Millimoles per liter | Standard Deviation 0.7047 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 1 (Month 1), n=351 | 0.06 Millimoles per liter | Standard Deviation 0.885 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 1a (Month 2), n=1 | -0.30 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 2 (Month 3), n=321 | 0.17 Millimoles per liter | Standard Deviation 1.002 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 2a (Month 4), n=1 | 0.40 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 3 (Month 6), n=278 | 0.12 Millimoles per liter | Standard Deviation 0.804 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 4 (Month 9), n=247 | 0.16 Millimoles per liter | Standard Deviation 1.066 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 5 (Month 12), n=227 | 0.16 Millimoles per liter | Standard Deviation 0.906 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 6 (Month 16), n=199 | 0.10 Millimoles per liter | Standard Deviation 0.851 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 8 (Month 24), n=161 | 0.12 Millimoles per liter | Standard Deviation 0.858 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 9 (Month 28), n=142 | 0.04 Millimoles per liter | Standard Deviation 0.842 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 10 (Month 32), n=126 | 0.03 Millimoles per liter | Standard Deviation 0.976 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 11 (Month 36), n=115 | 0.08 Millimoles per liter | Standard Deviation 0.951 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 12 (Month 40), n=108 | 0.06 Millimoles per liter | Standard Deviation 0.938 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 13 (Month 44), n=100 | 0.07 Millimoles per liter | Standard Deviation 0.912 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 14 (Month 48), n=101 | -0.04 Millimoles per liter | Standard Deviation 0.881 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 16 (Month 56), n=75 | 0.19 Millimoles per liter | Standard Deviation 0.931 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 17 (Month 60), n=89 | 0.08 Millimoles per liter | Standard Deviation 0.773 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 18 (Month 64), n=55 | 0.14 Millimoles per liter | Standard Deviation 1.125 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 20 (Month 72), n=58 | 0.16 Millimoles per liter | Standard Deviation 0.878 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 21 (Month 76), n=40 | 0.03 Millimoles per liter | Standard Deviation 0.895 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 22 (Month 80), n=35 | 0.29 Millimoles per liter | Standard Deviation 1.116 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 23 (Month 84), n=32 | -0.01 Millimoles per liter | Standard Deviation 0.903 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 24 (Month 88), n=28 | 0.14 Millimoles per liter | Standard Deviation 1.017 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 26 (Month 96), n=26 | 0.50 Millimoles per liter | Standard Deviation 1.381 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 27 (Month 100), n=20 | 0.18 Millimoles per liter | Standard Deviation 1.022 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 28 (Month 104), n=16 | 0.74 Millimoles per liter | Standard Deviation 0.916 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 29 (Month 108), n=13 | 0.25 Millimoles per liter | Standard Deviation 0.989 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 30 (Month 112), n=4 | 0.65 Millimoles per liter | Standard Deviation 0.839 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 31 (Month 116), n=3 | 0.70 Millimoles per liter | Standard Deviation 1.127 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 32 (Month 120), n=1 | -0.30 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Follow up, n=259 | 0.18 Millimoles per liter | Standard Deviation 1.068 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 1 (Month 1), n=351 | 0.017 Millimoles per liter | Standard Deviation 0.1991 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 1a (Month 2), n=1 | 0.030 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 2a (Month 4), n=1 | 0.160 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 3 (Month 6), n=278 | -0.001 Millimoles per liter | Standard Deviation 0.2125 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 4 (Month 9), n=247 | -0.009 Millimoles per liter | Standard Deviation 0.1912 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 5 (Month 12), n=227 | -0.016 Millimoles per liter | Standard Deviation 0.213 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 6 (Month 16), n=199 | -0.023 Millimoles per liter | Standard Deviation 0.1994 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 7 (Month 20), n=176 | -0.022 Millimoles per liter | Standard Deviation 0.2224 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 8 (Month 24), n=161 | -0.012 Millimoles per liter | Standard Deviation 0.2332 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 9 (Month 28), n=142 | -0.011 Millimoles per liter | Standard Deviation 0.2146 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 10 (Month 32), n=126 | -0.005 Millimoles per liter | Standard Deviation 0.2231 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 11 (Month 36), n=115 | -0.026 Millimoles per liter | Standard Deviation 0.2284 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 12 (Month 40), n=108 | -0.030 Millimoles per liter | Standard Deviation 0.2585 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 13 (Month 44), n=100 | -0.026 Millimoles per liter | Standard Deviation 0.2241 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 14 (Month 48), n=101 | -0.050 Millimoles per liter | Standard Deviation 0.2331 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 15 (Month 52), n=88 | -0.054 Millimoles per liter | Standard Deviation 0.2207 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 16 (Month 56), n=75 | -0.052 Millimoles per liter | Standard Deviation 0.2465 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 17 (Month 60), n=89 | -0.047 Millimoles per liter | Standard Deviation 0.2419 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 18 (Month 64), n=55 | -0.059 Millimoles per liter | Standard Deviation 0.254 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 19 (Month 68), n=49 | -0.047 Millimoles per liter | Standard Deviation 0.2905 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 20 (Month 72), n=58 | -0.076 Millimoles per liter | Standard Deviation 0.2502 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 21 (Month 76), n=40 | -0.074 Millimoles per liter | Standard Deviation 0.2503 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 22 (Month 80), n=35 | -0.071 Millimoles per liter | Standard Deviation 0.293 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 23 (Month 84), n=32 | -0.068 Millimoles per liter | Standard Deviation 0.3006 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 24 (Month 88), n=28 | -0.115 Millimoles per liter | Standard Deviation 0.346 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 25 (Month 92), n=25 | -0.130 Millimoles per liter | Standard Deviation 0.3251 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 26 (Month 96), n=26 | -0.098 Millimoles per liter | Standard Deviation 0.282 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 27 (Month 100), n=20 | -0.197 Millimoles per liter | Standard Deviation 0.303 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 28 (Month 104), n=16 | -0.261 Millimoles per liter | Standard Deviation 0.2665 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 29 (Month 108), n=13 | -0.300 Millimoles per liter | Standard Deviation 0.1534 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 30 (Month 112), n=4 | -0.065 Millimoles per liter | Standard Deviation 0.0603 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 31 (Month 116), n=3 | -0.260 Millimoles per liter | Standard Deviation 0 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 32 (Month 120), n=1 | -0.320 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Follow up, n=260 | -0.038 Millimoles per liter | Standard Deviation 0.2237 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 1 (Month 1), n=351 | -0.02 Millimoles per liter | Standard Deviation 0.426 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 1a (Month 2), n=1 | -0.40 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 2a (Month 4), n=1 | 0.40 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 5 (Month 12), n=230 | -0.07 Millimoles per liter | Standard Deviation 0.44 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 6 (Month 16), n=199 | 0.00 Millimoles per liter | Standard Deviation 0.436 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 10 (Month 32), n=127 | -0.01 Millimoles per liter | Standard Deviation 0.451 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 11 (Month 36), n=116 | -0.01 Millimoles per liter | Standard Deviation 0.457 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 25 (Month 92), n=25 | -0.01 Millimoles per liter | Standard Deviation 0.488 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 26 (Month 96), n=26 | -0.02 Millimoles per liter | Standard Deviation 0.603 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 27 (Month 100), n=20 | -0.09 Millimoles per liter | Standard Deviation 0.609 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 28 (Month 104), n=16 | -0.18 Millimoles per liter | Standard Deviation 0.481 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 29 (Month 108), n=13 | -0.09 Millimoles per liter | Standard Deviation 0.647 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 30 (Month 112), n=4 | -0.38 Millimoles per liter | Standard Deviation 0.574 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 31 (Month 116), n=3 | -0.83 Millimoles per liter | Standard Deviation 0.611 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Follow up, n=258 | -0.02 Millimoles per liter | Standard Deviation 0.456 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 1 (Month 1), n=352 | -0.3 Millimoles per liter | Standard Deviation 3.6 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 1a (Month 2), n=1 | 0.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 2 (Month 3), n=324 | -0.1 Millimoles per liter | Standard Deviation 3.52 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 2a (Month 4), n=1 | 1.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 3 (Month 6), n=280 | 0.8 Millimoles per liter | Standard Deviation 3.49 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 4 (Month 9), n=248 | 0.5 Millimoles per liter | Standard Deviation 3.5 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 5 (Month 12), n=231 | 0.6 Millimoles per liter | Standard Deviation 3.84 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 6 (Month 16), n=200 | 0.9 Millimoles per liter | Standard Deviation 3.81 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 7 (Month 20), n=176 | 1.1 Millimoles per liter | Standard Deviation 3.88 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 8 (Month 24), n=164 | 1.0 Millimoles per liter | Standard Deviation 4.38 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 9 (Month 28), n=143 | 1.6 Millimoles per liter | Standard Deviation 4.36 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 10 (Month 32), n=127 | 1.2 Millimoles per liter | Standard Deviation 4.08 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 11 (Month 36), n=118 | 1.3 Millimoles per liter | Standard Deviation 5.15 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 12 (Month 40), n=108 | 1.9 Millimoles per liter | Standard Deviation 4.25 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 13 (Month 44), n=103 | 1.7 Millimoles per liter | Standard Deviation 4.06 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 14 (Month 48), n=102 | 1.1 Millimoles per liter | Standard Deviation 4.44 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 15 (Month 52), n=89 | 1.8 Millimoles per liter | Standard Deviation 4.29 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 16 (Month 56), n=76 | 1.7 Millimoles per liter | Standard Deviation 3.75 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 17 (Month 60), n=91 | 1.8 Millimoles per liter | Standard Deviation 4.62 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 18 (Month 64), n=55 | 2.7 Millimoles per liter | Standard Deviation 3.32 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 19 (Month 68), n=51 | 2.2 Millimoles per liter | Standard Deviation 3.63 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 20 (Month 72), n=58 | 1.0 Millimoles per liter | Standard Deviation 4.46 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 22 (Month 80), n=35 | 2.0 Millimoles per liter | Standard Deviation 3.11 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 23 (Month 84), n=32 | 2.4 Millimoles per liter | Standard Deviation 3.72 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 24 (Month 88), n=28 | 1.9 Millimoles per liter | Standard Deviation 3.85 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 25 (Month 92), n=25 | 1.4 Millimoles per liter | Standard Deviation 5.45 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 26 (Month 96), n=26 | 1.8 Millimoles per liter | Standard Deviation 4.48 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 27 (Month 100), n=20 | 1.8 Millimoles per liter | Standard Deviation 4.76 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 28 (Month 104), n=16 | 0.9 Millimoles per liter | Standard Deviation 3.14 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 30 (Month 112), n=4 | -0.3 Millimoles per liter | Standard Deviation 5.85 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 31 (Month 116), n=3 | 0.7 Millimoles per liter | Standard Deviation 3.79 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 32 (Month 120), n=1 | -5.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Follow up, n=261 | 0.3 Millimoles per liter | Standard Deviation 3.91 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 1 (Month 1), n=351 | 0.583 Millimoles per liter | Standard Deviation 1.2933 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 1a (Month 2), n=1 | 2.860 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 4 (Month 9), n=248 | 0.642 Millimoles per liter | Standard Deviation 1.3781 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 5 (Month 12), n=228 | 0.599 Millimoles per liter | Standard Deviation 1.3323 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 6 (Month 16), n=200 | 0.656 Millimoles per liter | Standard Deviation 1.3598 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 8 (Month 24), n=163 | 0.652 Millimoles per liter | Standard Deviation 1.5332 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 9 (Month 28), n=142 | 0.578 Millimoles per liter | Standard Deviation 1.3512 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 10 (Month 32), n=126 | 0.748 Millimoles per liter | Standard Deviation 1.568 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 12 (Month 40), n=108 | 0.794 Millimoles per liter | Standard Deviation 1.5456 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 13 (Month 44), n=102 | 0.697 Millimoles per liter | Standard Deviation 1.5664 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 15 (Month 52), n=88 | 0.828 Millimoles per liter | Standard Deviation 1.4226 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 16 (Month 56), n=76 | 0.742 Millimoles per liter | Standard Deviation 1.3964 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 17 (Month 60), n=90 | 0.778 Millimoles per liter | Standard Deviation 1.5392 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 28 (Month 104), n=16 | 0.536 Millimoles per liter | Standard Deviation 0.9589 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 31 (Month 116), n=3 | 0.837 Millimoles per liter | Standard Deviation 1.6082 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 32 (Month 120), n=1 | -1.070 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 8 (Month 24), n=164 | 1.8 Millimoles per liter | Standard Deviation 4.42 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 9 (Month 28), n=143 | 2.1 Millimoles per liter | Standard Deviation 4.45 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 10 (Month 32), n=127 | 1.3 Millimoles per liter | Standard Deviation 4.22 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 11 (Month 36), n=118 | 1.3 Millimoles per liter | Standard Deviation 4.55 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 12 (Month 40), n=108 | 2.4 Millimoles per liter | Standard Deviation 4.68 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 13 (Month 44), n=103 | 2.2 Millimoles per liter | Standard Deviation 4.59 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 14 (Month 48), n=102 | 1.2 Millimoles per liter | Standard Deviation 4.91 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 15 (Month 52), n=89 | 2.0 Millimoles per liter | Standard Deviation 4.63 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 16 (Month 56), n=76 | 1.6 Millimoles per liter | Standard Deviation 4.51 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 17 (Month 60), n=91 | 1.3 Millimoles per liter | Standard Deviation 5.16 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 18 (Month 64), n=55 | 2.3 Millimoles per liter | Standard Deviation 3.33 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 19 (Month 68), n=51 | 0.9 Millimoles per liter | Standard Deviation 4.22 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 20 (Month 72), n=58 | 0.2 Millimoles per liter | Standard Deviation 5.33 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 21 (Month 76), n=40 | 0.6 Millimoles per liter | Standard Deviation 4.11 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 22 (Month 80), n=35 | 0.8 Millimoles per liter | Standard Deviation 3.3 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 23 (Month 84), n=32 | 1.1 Millimoles per liter | Standard Deviation 4.33 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 24 (Month 88), n=28 | 0.8 Millimoles per liter | Standard Deviation 3.94 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 26 (Month 96), n=26 | -0.4 Millimoles per liter | Standard Deviation 4.56 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 27 (Month 100), n=20 | 0.1 Millimoles per liter | Standard Deviation 5.31 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 2 (Month 3), n=322 | 0.108 Millimoles per liter | Standard Deviation 0.6368 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 23 (Month 84), n=32 | 0.077 Millimoles per liter | Standard Deviation 0.9637 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 24 (Month 88), n=28 | 0.310 Millimoles per liter | Standard Deviation 0.8553 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Cholesterol, Visit 32 (Month 120), n=1 | 0.050 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 7 (Month 20), n=176 | 0.02 Millimoles per liter | Standard Deviation 0.843 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 15 (Month 52), n=88 | 0.08 Millimoles per liter | Standard Deviation 0.745 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 19 (Month 68), n=49 | 0.05 Millimoles per liter | Standard Deviation 0.816 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Non-fasting Glucose, Visit 25 (Month 92), n=25 | 0.28 Millimoles per liter | Standard Deviation 1.105 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Phosphorus, Visit 2 (Month 3), n=320 | 0.014 Millimoles per liter | Standard Deviation 0.2011 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 3 (Month 6), n=279 | 0.623 Millimoles per liter | Standard Deviation 1.3294 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 1 (Month 1), n=344 | -0.2 Millimoles per liter | Standard Deviation 3.02 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 1a (Month 2), n=1 | -2.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 2 (Month 3), n=316 | -0.3 Millimoles per liter | Standard Deviation 3.34 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 3 (Month 6), n=272 | 0.0 Millimoles per liter | Standard Deviation 3.06 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 4 (Month 9), n=243 | -0.3 Millimoles per liter | Standard Deviation 3.22 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 5 (Month 12), n=221 | -0.8 Millimoles per liter | Standard Deviation 3.18 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 6 (Month 16), n=196 | -0.2 Millimoles per liter | Standard Deviation 3.11 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 7 (Month 20), n=171 | -0.2 Millimoles per liter | Standard Deviation 3.22 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 8 (Month 24), n=159 | -0.2 Millimoles per liter | Standard Deviation 3.26 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 9 (Month 28), n=140 | -0.1 Millimoles per liter | Standard Deviation 3.44 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 10 (Month 32), n=126 | -0.5 Millimoles per liter | Standard Deviation 3.74 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 11 (Month 36), n=116 | -0.4 Millimoles per liter | Standard Deviation 3.54 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 12 (Month 40), n=107 | 0.0 Millimoles per liter | Standard Deviation 3.52 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 13 (Month 44), n=100 | 0.4 Millimoles per liter | Standard Deviation 3.41 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 14 (Month 48), n=101 | -0.1 Millimoles per liter | Standard Deviation 3.56 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 15 (Month 52), n=86 | 0.5 Millimoles per liter | Standard Deviation 3.77 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 16 (Month 56), n=76 | -0.1 Millimoles per liter | Standard Deviation 3.07 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 17 (Month 60), n=90 | -0.1 Millimoles per liter | Standard Deviation 3.45 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 18 (Month 64), n=55 | -0.7 Millimoles per liter | Standard Deviation 3.93 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 19 (Month 68), n=49 | -1.1 Millimoles per liter | Standard Deviation 4.11 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 20 (Month 72), n=56 | -1.2 Millimoles per liter | Standard Deviation 3.81 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 21 (Month 76), n=39 | -0.2 Millimoles per liter | Standard Deviation 3.58 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 22 (Month 80), n=35 | -1.0 Millimoles per liter | Standard Deviation 3.24 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 23 (Month 84), n=32 | -1.3 Millimoles per liter | Standard Deviation 3.17 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 24 (Month 88), n=28 | -0.7 Millimoles per liter | Standard Deviation 3.56 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 25 (Month 92), n=25 | -1.8 Millimoles per liter | Standard Deviation 3.15 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 26 (Month 96), n=25 | -1.0 Millimoles per liter | Standard Deviation 3.48 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 27 (Month 100), n=20 | -1.3 Millimoles per liter | Standard Deviation 3.91 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 28 (Month 104), n=15 | -1.9 Millimoles per liter | Standard Deviation 3.7 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 29 (Month 108), n=13 | -1.8 Millimoles per liter | Standard Deviation 2.35 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 30 (Month 112), n=4 | -2.0 Millimoles per liter | Standard Deviation 1.41 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 31 (Month 116), n=3 | 3.3 Millimoles per liter | Standard Deviation 6.11 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Visit 32 (Month 120), n=1 | 2.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Bicarbonate, Follow up, n=256 | -1.0 Millimoles per liter | Standard Deviation 3.19 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 1 (Month 1), n=352 | 0.000 Millimoles per liter | Standard Deviation 0.1187 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 1a (Month 2), n=1 | -0.250 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 2 (Month 3), n=322 | 0.008 Millimoles per liter | Standard Deviation 0.1146 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 2a (Month 4), n=1 | -0.100 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 3 (Month 6), n=279 | 0.018 Millimoles per liter | Standard Deviation 0.1169 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 4 (Month 9), n=248 | 0.022 Millimoles per liter | Standard Deviation 0.1187 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 5 (Month 12), n=228 | 0.010 Millimoles per liter | Standard Deviation 0.1269 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 6 (Month 16), n=200 | 0.005 Millimoles per liter | Standard Deviation 0.1168 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 7 (Month 20), n=176 | 0.005 Millimoles per liter | Standard Deviation 0.1118 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 8 (Month 24), n=163 | 0.014 Millimoles per liter | Standard Deviation 0.1193 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 9 (Month 28), n=142 | 0.015 Millimoles per liter | Standard Deviation 0.1154 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 10 (Month 32), n=126 | 0.023 Millimoles per liter | Standard Deviation 0.1161 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 11 (Month 36), n=116 | 0.017 Millimoles per liter | Standard Deviation 0.1274 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 12 (Month 40), n=108 | 0.035 Millimoles per liter | Standard Deviation 0.1239 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 13 (Month 44), n=101 | 0.028 Millimoles per liter | Standard Deviation 0.1168 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 14 (Month 48), n=101 | 0.025 Millimoles per liter | Standard Deviation 0.1176 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 15 (Month 52), n=88 | 0.020 Millimoles per liter | Standard Deviation 0.1225 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 16 (Month 56), n=76 | 0.016 Millimoles per liter | Standard Deviation 0.1227 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 17 (Month 60), n=90 | 0.008 Millimoles per liter | Standard Deviation 0.1172 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 18 (Month 64), n=55 | -0.007 Millimoles per liter | Standard Deviation 0.127 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 19 (Month 68), n=51 | 0.019 Millimoles per liter | Standard Deviation 0.1177 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 20 (Month 72), n=58 | -0.012 Millimoles per liter | Standard Deviation 0.1298 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 21 (Month 76), n=40 | 0.020 Millimoles per liter | Standard Deviation 0.1257 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 22 (Month 80), n=35 | 0.079 Millimoles per liter | Standard Deviation 0.1531 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 23 (Month 84), n=32 | 0.038 Millimoles per liter | Standard Deviation 0.1113 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 24 (Month 88), n=28 | 0.034 Millimoles per liter | Standard Deviation 0.1497 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 25 (Month 92), n=25 | 0.089 Millimoles per liter | Standard Deviation 0.156 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 26 (Month 96), n=26 | 0.075 Millimoles per liter | Standard Deviation 0.1636 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 27 (Month 100), n=20 | 0.121 Millimoles per liter | Standard Deviation 0.1552 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 29 (Month 108), n=13 | 0.080 Millimoles per liter | Standard Deviation 0.1297 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 30 (Month 112), n=4 | 0.133 Millimoles per liter | Standard Deviation 0.1063 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 31 (Month 116), n=3 | 0.053 Millimoles per liter | Standard Deviation 0.1124 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Visit 32 (Month 120), n=1 | -0.040 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Calcium, Follow up, n=261 | 0.031 Millimoles per liter | Standard Deviation 0.1245 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 1 (Month 1), n=352 | 0.1 Millimoles per liter | Standard Deviation 3.48 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 1a (Month 2), n=1 | 1.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 2 (Month 3), n=322 | 0.3 Millimoles per liter | Standard Deviation 3.49 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 2a (Month 4), n=1 | 2.0 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 3 (Month 6), n=279 | 0.9 Millimoles per liter | Standard Deviation 3.52 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 4 (Month 9), n=248 | 1.0 Millimoles per liter | Standard Deviation 3.46 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 5 (Month 12), n=228 | 1.2 Millimoles per liter | Standard Deviation 3.75 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 6 (Month 16), n=200 | 1.8 Millimoles per liter | Standard Deviation 3.73 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Chloride, Visit 7 (Month 20), n=176 | 2.0 Millimoles per liter | Standard Deviation 4.09 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 7 (Month 20), n=176 | 0.750 Millimoles per liter | Standard Deviation 1.3893 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 11 (Month 36), n=117 | 0.552 Millimoles per liter | Standard Deviation 1.665 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 14 (Month 48), n=101 | 0.792 Millimoles per liter | Standard Deviation 1.7321 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 18 (Month 64), n=55 | 0.766 Millimoles per liter | Standard Deviation 1.598 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 19 (Month 68), n=51 | 0.791 Millimoles per liter | Standard Deviation 1.3485 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 20 (Month 72), n=58 | 0.794 Millimoles per liter | Standard Deviation 1.5895 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 21 (Month 76), n=40 | 1.152 Millimoles per liter | Standard Deviation 1.3824 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 22 (Month 80), n=35 | 0.939 Millimoles per liter | Standard Deviation 1.2432 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 23 (Month 84), n=32 | 0.781 Millimoles per liter | Standard Deviation 1.3376 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 24 (Month 88), n=28 | 0.791 Millimoles per liter | Standard Deviation 1.0485 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 25 (Month 92), n=25 | 0.529 Millimoles per liter | Standard Deviation 1.638 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 26 (Month 96), n=26 | 0.811 Millimoles per liter | Standard Deviation 1.4025 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 27 (Month 100), n=20 | 0.501 Millimoles per liter | Standard Deviation 1.1668 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 29 (Month 108), n=13 | 0.523 Millimoles per liter | Standard Deviation 1.2418 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 30 (Month 112), n=4 | 0.983 Millimoles per liter | Standard Deviation 1.0297 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Follow up, n=260 | 0.158 Millimoles per liter | Standard Deviation 1.2473 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 2 (Month 3), n=322 | -0.05 Millimoles per liter | Standard Deviation 0.41 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 3 (Month 6), n=279 | -0.04 Millimoles per liter | Standard Deviation 0.424 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 4 (Month 9), n=247 | -0.08 Millimoles per liter | Standard Deviation 0.427 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 7 (Month 20), n=174 | -0.02 Millimoles per liter | Standard Deviation 0.434 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 8 (Month 24), n=162 | -0.03 Millimoles per liter | Standard Deviation 0.43 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 9 (Month 28), n=143 | -0.01 Millimoles per liter | Standard Deviation 0.434 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 12 (Month 40), n=108 | -0.05 Millimoles per liter | Standard Deviation 0.475 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 13 (Month 44), n=102 | -0.06 Millimoles per liter | Standard Deviation 0.466 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 14 (Month 48), n=101 | -0.01 Millimoles per liter | Standard Deviation 0.443 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 15 (Month 52), n=89 | -0.01 Millimoles per liter | Standard Deviation 0.436 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 16 (Month 56), n=75 | 0.00 Millimoles per liter | Standard Deviation 0.506 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 17 (Month 60), n=89 | -0.05 Millimoles per liter | Standard Deviation 0.477 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 18 (Month 64), n=55 | -0.12 Millimoles per liter | Standard Deviation 0.468 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 19 (Month 68), n=50 | -0.03 Millimoles per liter | Standard Deviation 0.484 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 20 (Month 72), n=58 | -0.10 Millimoles per liter | Standard Deviation 0.485 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 21 (Month 76), n=39 | -0.11 Millimoles per liter | Standard Deviation 0.469 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 22 (Month 80), n=35 | -0.08 Millimoles per liter | Standard Deviation 0.461 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 23 (Month 84), n=32 | 0.01 Millimoles per liter | Standard Deviation 0.523 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 24 (Month 88), n=28 | -0.05 Millimoles per liter | Standard Deviation 0.517 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Potassium, Visit 32 (Month 120), n=1 | -0.30 Millimoles per liter | — |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 21 (Month 76), n=40 | 2.2 Millimoles per liter | Standard Deviation 3.82 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Sodium, Visit 29 (Month 108), n=13 | 0.5 Millimoles per liter | Standard Deviation 4.58 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 2 (Month 3), n=322 | 0.606 Millimoles per liter | Standard Deviation 1.2846 |
| Retigabine | Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea | Urea, Visit 2a (Month 4), n=1 | 1.780 Millimoles per liter | — |
Primary
Change From Baseline in Body Temperature
Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 26 (Month 96), n=26 | -0.10 Degree Celsius | Standard Deviation 0.299 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 31 (Month 116), n=3 | -0.20 Degree Celsius | Standard Deviation 0.2 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 1 (Month 1), n=350 | 0.02 Degree Celsius | Standard Deviation 0.386 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 2 (Month 3), n=318 | 0.02 Degree Celsius | Standard Deviation 0.358 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 3 (Month 6), n=280 | 0.03 Degree Celsius | Standard Deviation 0.384 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 4 (Month 9), n=244 | 0.00 Degree Celsius | Standard Deviation 0.38 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 5 (Month 12), n=229 | 0.01 Degree Celsius | Standard Deviation 0.392 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 6 (Month 16), n=197 | 0.02 Degree Celsius | Standard Deviation 0.362 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 7 (Month 20), n=176 | 0.04 Degree Celsius | Standard Deviation 0.381 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 8 (Month 24), n=161 | 0.02 Degree Celsius | Standard Deviation 0.387 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 9 (Month 28), n=143 | 0.01 Degree Celsius | Standard Deviation 0.407 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 10 (Month 32), n=125 | 0.02 Degree Celsius | Standard Deviation 0.362 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 11 (Month 36), n=118 | 0.02 Degree Celsius | Standard Deviation 0.385 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 12 (Month 40), n=109 | 0.01 Degree Celsius | Standard Deviation 0.404 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 13 (Month 44), n=101 | 0.04 Degree Celsius | Standard Deviation 0.387 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 14 (Month 48), n=100 | 0.05 Degree Celsius | Standard Deviation 0.382 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 15 (Month 52), n=88 | -0.02 Degree Celsius | Standard Deviation 0.396 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 16 (Month 56), n=74 | -0.01 Degree Celsius | Standard Deviation 0.393 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 17 (Month 60), n=89 | 0.03 Degree Celsius | Standard Deviation 0.391 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 18 (Month 64), n=58 | -0.01 Degree Celsius | Standard Deviation 0.306 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 19 (Month 68), n=53 | 0.05 Degree Celsius | Standard Deviation 0.318 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 20 (Month 72), n=59 | 0.06 Degree Celsius | Standard Deviation 0.373 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 21 (Month 76), n=42 | 0.06 Degree Celsius | Standard Deviation 0.306 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 22 (Month 80), n=37 | -0.04 Degree Celsius | Standard Deviation 0.362 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 23 (Month 84), n=32 | 0.05 Degree Celsius | Standard Deviation 0.324 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 24 (Month 88), n=29 | -0.06 Degree Celsius | Standard Deviation 0.313 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 25 (Month 92), n=25 | 0.00 Degree Celsius | Standard Deviation 0.289 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 27 (Month 100), n=20 | -0.03 Degree Celsius | Standard Deviation 0.285 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 28 (Month 104), n=17 | -0.02 Degree Celsius | Standard Deviation 0.326 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 29 (Month 108), n=13 | 0.04 Degree Celsius | Standard Deviation 0.275 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 30 (Month 112), n=4 | -0.02 Degree Celsius | Standard Deviation 0.126 |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Visit 32 (Month 120), n=1 | 0.10 Degree Celsius | — |
| Retigabine | Change From Baseline in Body Temperature | Body temperature, Follow up, n=261 | 0.03 Degree Celsius | Standard Deviation 0.397 |
Primary
Change From Baseline in Body Weight
Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 5 (Month 12), n=235 | 1.56 Kilograms | Standard Deviation 4.764 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 20 (Month 72), n=61 | 1.65 Kilograms | Standard Deviation 8.774 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Follow up, n=267 | 1.34 Kilograms | Standard Deviation 5.87 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 1 (Month 1), n=356 | 1.19 Kilograms | Standard Deviation 3.125 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 2 (Month 3), n=325 | 1.37 Kilograms | Standard Deviation 3.63 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 3 (Month 6), n=287 | 1.51 Kilograms | Standard Deviation 4.528 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 4 (Month 9), n=252 | 1.08 Kilograms | Standard Deviation 5.068 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 6 (Month 16), n=202 | 1.98 Kilograms | Standard Deviation 5.382 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 7 (Month 20), n=181 | 1.79 Kilograms | Standard Deviation 5.762 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 8 (Month 24), n=167 | 1.20 Kilograms | Standard Deviation 6.571 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 9 (Month 28), n=147 | 1.67 Kilograms | Standard Deviation 6.101 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 10 (Month 32), n=128 | 1.75 Kilograms | Standard Deviation 7.103 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 11 (Month 36), n=121 | 2.07 Kilograms | Standard Deviation 7.151 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 12 (Month 40), 112 | 2.12 Kilograms | Standard Deviation 7.077 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 13 (Month 44), n=105 | 1.09 Kilograms | Standard Deviation 7.469 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 14 (Month 48), n=104 | 1.08 Kilograms | Standard Deviation 8.007 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 15 (Month 52), n=91 | 0.66 Kilograms | Standard Deviation 7.539 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 16 (Month 56), n=77 | 0.71 Kilograms | Standard Deviation 7.248 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 17 (Month 60), n=91 | 1.31 Kilograms | Standard Deviation 8.082 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 18 (Month 64), n=58 | 1.32 Kilograms | Standard Deviation 7.541 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 19 (Month 68), n=53 | 1.49 Kilograms | Standard Deviation 8.036 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 21 (Month 76), n=43 | 1.71 Kilograms | Standard Deviation 9.355 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 22 (Month 80), n=37 | 2.30 Kilograms | Standard Deviation 9.311 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 23 (Month 84), n=32 | 2.00 Kilograms | Standard Deviation 9.522 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 24 (Month 88), n=29 | 1.12 Kilograms | Standard Deviation 9.633 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 25 (Month 92), n=25 | 0.83 Kilograms | Standard Deviation 10.845 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 26 (Month 96), n=26 | 0.12 Kilograms | Standard Deviation 14.47 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 27 (Month 100), n=20 | 1.57 Kilograms | Standard Deviation 11.382 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 28 (Month 104), n=17 | 1.62 Kilograms | Standard Deviation 10.715 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 29 (Month 108), n=13 | 2.32 Kilograms | Standard Deviation 13.914 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 30 (Month 112), n=4 | 4.85 Kilograms | Standard Deviation 17.693 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 31 (Month 116), n=3 | 9.73 Kilograms | Standard Deviation 17.234 |
| Retigabine | Change From Baseline in Body Weight | Body weight, Visit 32 (Month 120), n=1 | 0.50 Kilograms | — |
Primary
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid
Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 9 (Month 28), n=142 | -0.2 Micromoles per liter | Standard Deviation 9.98 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 15 (Month 52), n=88 | 0.8 Micromoles per liter | Standard Deviation 9.55 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 16 (Month 56), n=75 | 1.1 Micromoles per liter | Standard Deviation 22.92 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Follow up, n=260 | 0.6 Micromoles per liter | Standard Deviation 9.99 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 1 (Month 1), n=351 | 3.5 Micromoles per liter | Standard Deviation 3.41 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 2 (Month 3), n=322 | 3.5 Micromoles per liter | Standard Deviation 3.57 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 2a (Month 4), n=1 | 6.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 3 (Month 6), n=278 | 3.6 Micromoles per liter | Standard Deviation 3.62 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 7 (Month 20), n=176 | 3.7 Micromoles per liter | Standard Deviation 3.6 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 10 (Month 32), n=126 | 4.1 Micromoles per liter | Standard Deviation 3.68 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 11 (Month 36), n=116 | 4.0 Micromoles per liter | Standard Deviation 3.82 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 12 (Month 40), n=107 | 3.7 Micromoles per liter | Standard Deviation 3.44 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 18 (Month 64), n=55 | 3.7 Micromoles per liter | Standard Deviation 3.68 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 23 (Month 84), n=32 | 3.4 Micromoles per liter | Standard Deviation 4.01 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 24 (Month 88), n=28 | 3.6 Micromoles per liter | Standard Deviation 5.04 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 25 (Month 92), n=25 | 5.5 Micromoles per liter | Standard Deviation 4.57 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Follow up, n=258 | 0.0 Micromoles per liter | Standard Deviation 2.92 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 1 (Month 1), n=352 | 2.1 Micromoles per liter | Standard Deviation 38.02 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 1a (Month 2), n=1 | 41.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 2 (Month 3), n=322 | 5.5 Micromoles per liter | Standard Deviation 42.3 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 2a (Month 4), n=1 | 107.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 3 (Month 6), n=279 | 4.3 Micromoles per liter | Standard Deviation 44.39 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 4 (Month 9), n=248 | 7.8 Micromoles per liter | Standard Deviation 41.6 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 9 (Month 28), n=142 | 7.7 Micromoles per liter | Standard Deviation 59.32 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 10 (Month 32), n=126 | 8.7 Micromoles per liter | Standard Deviation 55.37 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 16 (Month 56), n=76 | 12.0 Micromoles per liter | Standard Deviation 60.26 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 17 (Month 60), n=90 | 14.7 Micromoles per liter | Standard Deviation 61.14 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 24 (Month 88), n=28 | 14.0 Micromoles per liter | Standard Deviation 72.96 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 30 (Month 112), n=4 | 46.3 Micromoles per liter | Standard Deviation 87.78 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 31 (Month 116), n=3 | -8.0 Micromoles per liter | Standard Deviation 37.24 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 32 (Month 120), n=1 | -23.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 1 (Month 1), n=351 | 1.8 Micromoles per liter | Standard Deviation 12.85 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 1a (Month 2), n=1 | 0.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 2 (Month 3), n=320 | 0.9 Micromoles per liter | Standard Deviation 8.49 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 2a (Month 4), n=1 | 9.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 3 (Month 6), n=278 | 0.7 Micromoles per liter | Standard Deviation 8.89 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 4 (Month 9), n=247 | 0.1 Micromoles per liter | Standard Deviation 9.04 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 5 (Month 12), n=227 | 0.0 Micromoles per liter | Standard Deviation 9.33 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 6 (Month 16), n=199 | 0.8 Micromoles per liter | Standard Deviation 10.14 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 7 (Month 20), n=176 | 0.6 Micromoles per liter | Standard Deviation 9.84 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 8 (Month 24), n=161 | 0.0 Micromoles per liter | Standard Deviation 8.81 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 10 (Month 32), n=126 | 1.3 Micromoles per liter | Standard Deviation 10.98 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 11 (Month 36), n=115 | -0.3 Micromoles per liter | Standard Deviation 10.13 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 12 (Month 40), n=108 | 0.8 Micromoles per liter | Standard Deviation 10.3 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 13 (Month 44), n=101 | 0.5 Micromoles per liter | Standard Deviation 10.7 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 14 (Month 48), n=101 | -0.3 Micromoles per liter | Standard Deviation 10.49 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 17 (Month 60), n=89 | -1.6 Micromoles per liter | Standard Deviation 10.31 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 18 (Month 64), n=55 | -0.7 Micromoles per liter | Standard Deviation 11.09 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 19 (Month 68), n=50 | -0.9 Micromoles per liter | Standard Deviation 13.22 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 20 (Month 72), n=58 | -3.6 Micromoles per liter | Standard Deviation 11.31 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 21 (Month 76), n=40 | -0.7 Micromoles per liter | Standard Deviation 13.1 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 22 (Month 80), n=35 | -2.2 Micromoles per liter | Standard Deviation 11.98 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 23 (Month 84), n=32 | -1.4 Micromoles per liter | Standard Deviation 12.5 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 24 (Month 88), n=28 | -4.1 Micromoles per liter | Standard Deviation 12.03 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 25 (Month 92), n=25 | -3.2 Micromoles per liter | Standard Deviation 10.84 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 26 (Month 96), n=26 | -2.6 Micromoles per liter | Standard Deviation 13.67 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 27 (Month 100), n=20 | -3.9 Micromoles per liter | Standard Deviation 11.05 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 28 (Month 104), n=16 | -4.2 Micromoles per liter | Standard Deviation 10.63 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 29 (Month 108), n=13 | -7.7 Micromoles per liter | Standard Deviation 13.98 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 30 (Month 112), n=4 | -6.3 Micromoles per liter | Standard Deviation 6.85 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 31 (Month 116), n=3 | -18.7 Micromoles per liter | Standard Deviation 8.5 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Creatinine, Visit 32 (Month 120), n=1 | -19.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 1a (Month 2), n=1 | 0.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 4 (Month 9), n=245 | 3.5 Micromoles per liter | Standard Deviation 3.63 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 5 (Month 12), n=227 | 3.4 Micromoles per liter | Standard Deviation 3.56 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 6 (Month 16), n=200 | 3.6 Micromoles per liter | Standard Deviation 3.69 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 8 (Month 24), n=162 | 3.8 Micromoles per liter | Standard Deviation 3.7 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 9 (Month 28), n=141 | 3.7 Micromoles per liter | Standard Deviation 3.57 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 13 (Month 44), n=101 | 3.9 Micromoles per liter | Standard Deviation 3.46 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 14 (Month 48), n=100 | 3.7 Micromoles per liter | Standard Deviation 3.67 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 15 (Month 52), n=88 | 3.7 Micromoles per liter | Standard Deviation 3.37 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 16 (Month 56), n=76 | 3.6 Micromoles per liter | Standard Deviation 3.47 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 17 (Month 60), n=90 | 3.8 Micromoles per liter | Standard Deviation 3.36 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 19 (Month 68), n=51 | 3.1 Micromoles per liter | Standard Deviation 4.12 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 20 (Month 72), n=58 | 3.3 Micromoles per liter | Standard Deviation 3.69 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 21 (Month 76), n=40 | 3.7 Micromoles per liter | Standard Deviation 4.02 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 22 (Month 80), n=35 | 3.2 Micromoles per liter | Standard Deviation 4.22 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 26 (Month 96), n=26 | 5.5 Micromoles per liter | Standard Deviation 6.59 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 27 (Month 100), n=20 | 5.2 Micromoles per liter | Standard Deviation 6.29 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 28 (Month 104), n=16 | 5.8 Micromoles per liter | Standard Deviation 5.01 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 29 (Month 108), n=13 | 5.5 Micromoles per liter | Standard Deviation 8.32 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 30 (Month 112), n=4 | 5.0 Micromoles per liter | Standard Deviation 3.65 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 31 (Month 116), n=3 | 2.7 Micromoles per liter | Standard Deviation 6.03 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Total Bilirubin, Visit 32 (Month 120), n=1 | 11.0 Micromoles per liter | — |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 5 (Month 12), n=228 | 5.3 Micromoles per liter | Standard Deviation 45.9 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 6 (Month 16), n=200 | 7.9 Micromoles per liter | Standard Deviation 49.61 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 7 (Month 20), n=176 | 8.8 Micromoles per liter | Standard Deviation 50.55 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 8 (Month 24), n=163 | 10.1 Micromoles per liter | Standard Deviation 54.77 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 11 (Month 36), n=116 | 9.8 Micromoles per liter | Standard Deviation 55.78 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 12 (Month 40), n=108 | 13.8 Micromoles per liter | Standard Deviation 64.68 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 13 (Month 44), n=101 | 13.4 Micromoles per liter | Standard Deviation 61.73 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 14 (Month 48), n=101 | 6.8 Micromoles per liter | Standard Deviation 61.69 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 15 (Month 52), n=88 | 14.2 Micromoles per liter | Standard Deviation 69.08 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 18 (Month 64), n=55 | 14.8 Micromoles per liter | Standard Deviation 58.21 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 19 (Month 68), n=50 | 25.2 Micromoles per liter | Standard Deviation 62.64 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 20 (Month 72), n=58 | 14.4 Micromoles per liter | Standard Deviation 62.38 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 21 (Month 76), n=40 | 25.5 Micromoles per liter | Standard Deviation 67.33 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 22 (Month 80), n=35 | 18.3 Micromoles per liter | Standard Deviation 63.64 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 23 (Month 84), n=32 | 21.4 Micromoles per liter | Standard Deviation 60.2 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 25 (Month 92), n=25 | 29.6 Micromoles per liter | Standard Deviation 79.56 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 26 (Month 96), n=26 | 14.3 Micromoles per liter | Standard Deviation 69.23 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 27 (Month 100), n=20 | 14.2 Micromoles per liter | Standard Deviation 71.63 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 28 (Month 104), n=16 | -1.8 Micromoles per liter | Standard Deviation 59.67 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Visit 29 (Month 108), n=13 | 9.2 Micromoles per liter | Standard Deviation 74.02 |
| Retigabine | Change From Baseline in Creatinine, Total Bilirubin and Uric Acid | Uric acid, Follow up, n=261 | 11.7 Micromoles per liter | Standard Deviation 45.09 |
Primary
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia
A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Friedericia's formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 23 (Month 84), n=32 | 3.4 Milliseconds | Standard Deviation 18.65 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 14 (Month 48), n=96 | 7.0 Milliseconds | Standard Deviation 22.57 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 1 (Month 1), n=355 | 0.1 Milliseconds | Standard Deviation 13.47 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 2 (Month 3), n=324 | -0.4 Milliseconds | Standard Deviation 11.95 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 3 (Month 6), n=278 | -1.0 Milliseconds | Standard Deviation 13.18 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 4 (Month 9), n=245 | -1.7 Milliseconds | Standard Deviation 12.74 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 5 (Month 12), n=233 | -1.7 Milliseconds | Standard Deviation 13.01 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 8 (Month 24), n=158 | -2.1 Milliseconds | Standard Deviation 15.23 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 11 (Month 36), n=113 | -1.6 Milliseconds | Standard Deviation 14.2 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 14 (Month 48), n=98 | 0.3 Milliseconds | Standard Deviation 13.3 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 17 (Month 60), n=87 | 0.7 Milliseconds | Standard Deviation 13.7 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 20 (Month 72), n=52 | 0.9 Milliseconds | Standard Deviation 14.07 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 23 (Month 84), n=30 | -3.5 Milliseconds | Standard Deviation 13.06 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 26 (Month 96), n=22 | -4.4 Milliseconds | Standard Deviation 11.96 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 29 (Month 108), n=13 | -1.9 Milliseconds | Standard Deviation 11.5 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Visit 32 (Month 120), n=1 | -23.7 Milliseconds | — |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | PR interval, Follow up, n=252 | -1.3 Milliseconds | Standard Deviation 12.83 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 1 (Month 1), n=357 | -0.6 Milliseconds | Standard Deviation 8.03 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 2 (Month 3), n=327 | -1.1 Milliseconds | Standard Deviation 7.53 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 3 (Month 6), n=282 | -1.2 Milliseconds | Standard Deviation 7.34 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 4 (Month 9), n=249 | -1.4 Milliseconds | Standard Deviation 6.59 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 5 (Month 12), n=235 | -0.1 Milliseconds | Standard Deviation 8.09 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 8 (Month 24), n=160 | -1.1 Milliseconds | Standard Deviation 7.74 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 11 (Month 36), n=116 | 1.5 Milliseconds | Standard Deviation 7.66 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 14 (Month 48), n=99 | 1.1 Milliseconds | Standard Deviation 7.92 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 17 (Month 60), n=89 | 3.3 Milliseconds | Standard Deviation 12.89 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 20 (Month 72), n=56 | 5.2 Milliseconds | Standard Deviation 16.42 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration Visit 26 (Month 96), n=23 | 3.5 Milliseconds | Standard Deviation 24.77 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 29 (Month 108), n=13 | 1.2 Milliseconds | Standard Deviation 7.73 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Visit 32 (Month 120), n=1 | 10.7 Milliseconds | — |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QRS duration, Follow up, n=254 | -0.1 Milliseconds | Standard Deviation 8.74 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 1 (Month 1), n=357 | 5.5 Milliseconds | Standard Deviation 23.66 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 2 (Month 3), n=324 | 4.8 Milliseconds | Standard Deviation 23.35 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 3 (Month 6), n=278 | 5.3 Milliseconds | Standard Deviation 23.1 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 4 (Month 9), n=246 | 3.9 Milliseconds | Standard Deviation 23.47 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 5 (Month 12), n=232 | 5.0 Milliseconds | Standard Deviation 24.37 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 8 (Month 24), n=157 | 3.4 Milliseconds | Standard Deviation 25.09 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 11 (Month 36), n=112 | 8.8 Milliseconds | Standard Deviation 24.66 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 17 (Month 60), n=89 | 7.9 Milliseconds | Standard Deviation 23.55 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 20 (Month 72), n=56 | 12.4 Milliseconds | Standard Deviation 28.3 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 23 (Month 84), n=32 | 8.4 Milliseconds | Standard Deviation 30.17 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 26 (Month 96), n=23 | 4.0 Milliseconds | Standard Deviation 31.01 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 29 (Month 108), n=13 | 0.8 Milliseconds | Standard Deviation 29.9 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Visit 32 (Month 120), n=1 | 64.0 Milliseconds | — |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QT interval, Follow up, n=254 | 1.2 Milliseconds | Standard Deviation 24.95 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 1 (Month 1, n=357 | 1.2 Milliseconds | Standard Deviation 18.07 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 2 (Month 3), n=324 | 1.6 Milliseconds | Standard Deviation 18.09 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 3 (Month 6), n=278 | 3.4 Milliseconds | Standard Deviation 16.97 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 4 (Month 9, n=246 | 4.4 Milliseconds | Standard Deviation 17.33 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 5 (Month 12), n=232 | 2.3 Milliseconds | Standard Deviation 16.61 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 8 (Month 24), n=157 | 6.6 Milliseconds | Standard Deviation 18.27 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 11 (Month 36), n=112 | 4.5 Milliseconds | Standard Deviation 18.1 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 14 (Month 48), n=96 | 5.6 Milliseconds | Standard Deviation 18.18 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 17 (Month 60), n=89 | 12.4 Milliseconds | Standard Deviation 25.68 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 20 (Month 72), n=56 | 15.6 Milliseconds | Standard Deviation 24.79 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 23 (Month 84), n=32 | 18.7 Milliseconds | Standard Deviation 23.9 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 26 (Month 96, n=23 | 19.7 Milliseconds | Standard Deviation 28.67 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 29 (Month 108), n=13 | 17.6 Milliseconds | Standard Deviation 21.09 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Visit 32 (Month 120), n=1 | 0.7 Milliseconds | — |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Bazett interval, Follow up, n=254 | 4.9 Milliseconds | Standard Deviation 18.39 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval, Visit 1 (Month 1),n=357 | 2.7 Milliseconds | Standard Deviation 15.72 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval Visit 2 (Month 3),n=324 | 2.7 Milliseconds | Standard Deviation 15.88 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 3 (Month 6),n=278 | 4.0 Milliseconds | Standard Deviation 15.59 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval, Visit 4 (Month 9),n=246 | 4.1 Milliseconds | Standard Deviation 15.86 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia intervalVisit 5 (Month 12),n=232 | 3.2 Milliseconds | Standard Deviation 15.62 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 8 (Month 24),n=157 | 5.4 Milliseconds | Standard Deviation 15 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia intervalVisit 11 (Month 36),n=112 | 5.9 Milliseconds | Standard Deviation 15.69 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 14 (Month 48),n=96 | 6.1 Milliseconds | Standard Deviation 15.08 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 17 (Month 60),n=89 | 10.8 Milliseconds | Standard Deviation 18.93 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia intervalVisit 20 (Month 72),n=56 | 14.4 Milliseconds | Standard Deviation 19.28 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia intervalVisit 23 (Month 84),n=32 | 15.0 Milliseconds | Standard Deviation 20.97 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 26 (Month 96),n=23 | 14.3 Milliseconds | Standard Deviation 22.9 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTcFriedericia intervalVisit 29 (Month 108)n=13 | 11.6 Milliseconds | Standard Deviation 17.76 |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTc Friedericia interval,Visit 32 (Month 120),n=1 | 23.7 Milliseconds | — |
| Retigabine | Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia | QTcFriedericia interval, Follow up,n=254 | 3.5 Milliseconds | Standard Deviation 16.58 |
Primary
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position
Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 1 (Month 1), n=358 | -0.4 Beats per minute | Standard Deviation 9.89 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 2 (Month 3), n=328 | -0.5 Beats per minute | Standard Deviation 9.93 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 3 (Month 6), n=287 | 0.1 Beats per minute | Standard Deviation 9.62 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 4 (Month 9), n=252 | 0.7 Beats per minute | Standard Deviation 9.69 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 5 (Month 12), n=235 | 0.0 Beats per minute | Standard Deviation 9.83 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 6 (Month 16), n=202 | 1.8 Beats per minute | Standard Deviation 10.56 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 7 (Month 20), n=181 | 2.3 Beats per minute | Standard Deviation 11.87 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 8 (Month 24), n=167 | 1.9 Beats per minute | Standard Deviation 10.28 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 9 (Month 28), n=147 | 2.7 Beats per minute | Standard Deviation 10.86 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 10 (Month 32), n=128 | 3.0 Beats per minute | Standard Deviation 10.5 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 11 (Month 36), n=121 | 0.8 Beats per minute | Standard Deviation 10.33 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 12 (Month 40), n=112 | 3.3 Beats per minute | Standard Deviation 11.2 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 13 (Month 44), n=105 | 1.8 Beats per minute | Standard Deviation 10.59 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 14 (Month 48), n=104 | 1.0 Beats per minute | Standard Deviation 10.78 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 15 (Month 52), n=91 | 2.0 Beats per minute | Standard Deviation 12.2 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 16 (Month 56), n=77 | 2.5 Beats per minute | Standard Deviation 10.7 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 17 (Month 60), n=92 | 0.9 Beats per minute | Standard Deviation 12.25 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 18 (Month 64), n=58 | 5.5 Beats per minute | Standard Deviation 10.44 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 19 (Month 68), n=53 | 2.4 Beats per minute | Standard Deviation 10.19 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 20 (Month 72), n=61 | 2.1 Beats per minute | Standard Deviation 12.23 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 21 (Month 76), n=43 | 2.8 Beats per minute | Standard Deviation 9.3 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 22 (Month 80), n=37 | 5.1 Beats per minute | Standard Deviation 10.13 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 23 (Month 84), n=32 | 3.5 Beats per minute | Standard Deviation 11.98 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 24 (Month 88), n=29 | 3.2 Beats per minute | Standard Deviation 13.66 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 25 (Month 92), n=25 | 3.9 Beats per minute | Standard Deviation 9.89 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 26 (Month 96), n=26 | 2.1 Beats per minute | Standard Deviation 10.37 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 27 (Month 100), n=20 | 3.1 Beats per minute | Standard Deviation 9.82 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 28 (Month 104), n=17 | 3.3 Beats per minute | Standard Deviation 8.62 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 29 (Month 108), n=13 | 0.5 Beats per minute | Standard Deviation 8.93 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 30 (Month 112), n=4 | 3.8 Beats per minute | Standard Deviation 12.84 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 31 (Month 116), n=3 | 7.7 Beats per minute | Standard Deviation 13.43 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Visit 32 (Month 120), n=1 | 11.0 Beats per minute | — |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Supine HR, Follow up, n=267 | 2.1 Beats per minute | Standard Deviation 10.44 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 1 (Month 1), n=357 | -0.1 Beats per minute | Standard Deviation 11.1 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 2 (Month 3), n=328 | -0.2 Beats per minute | Standard Deviation 11.01 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 3 (Month 6), n=287 | 0.3 Beats per minute | Standard Deviation 10.39 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 4 (Month 9), n=252 | 1.7 Beats per minute | Standard Deviation 11.53 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 5 (Month 12), n=235 | 0.1 Beats per minute | Standard Deviation 11.06 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 6 (Month 16), n=202 | 1.6 Beats per minute | Standard Deviation 12.35 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 7 (Month 20), n=181 | 1.4 Beats per minute | Standard Deviation 12.71 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 8 (Month 24), n=167 | 1.9 Beats per minute | Standard Deviation 10.93 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 9 (Month 28), n=147 | 1.6 Beats per minute | Standard Deviation 11.25 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 10 (Month 32), n=128 | 2.2 Beats per minute | Standard Deviation 11.92 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 11 (Month 36), n=121 | -0.6 Beats per minute | Standard Deviation 11.23 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 12 (Month 40), n=111 | 2.6 Beats per minute | Standard Deviation 12.94 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 13 (Month 44), n=105 | 2.8 Beats per minute | Standard Deviation 11.22 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 14 (Month 48), n=104 | 0.8 Beats per minute | Standard Deviation 11.81 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 15 (Month 52), n=91 | 3.1 Beats per minute | Standard Deviation 12.09 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 16 (Month 56), n=77 | 1.3 Beats per minute | Standard Deviation 12.12 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 17 (Month 60), n=92 | 0.6 Beats per minute | Standard Deviation 12.26 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 18 (Month 64), n=58 | 4.6 Beats per minute | Standard Deviation 12.09 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 19 (Month 68), n=52 | 1.3 Beats per minute | Standard Deviation 10.78 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 20 (Month 72), n=61 | 0.7 Beats per minute | Standard Deviation 13.45 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 21 (Month 76), n=43 | 0.3 Beats per minute | Standard Deviation 10.83 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 22 (Month 80), n=37 | 2.9 Beats per minute | Standard Deviation 10.96 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 23 (Month 84), n=32 | 2.3 Beats per minute | Standard Deviation 9.76 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 24 (Month 88), n=29 | 2.4 Beats per minute | Standard Deviation 10.64 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 25 (Month 92), n=25 | 3.6 Beats per minute | Standard Deviation 12.61 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 26 (Month 96), n=26 | 3.1 Beats per minute | Standard Deviation 12.01 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 27 (Month 100), n=20 | 5.2 Beats per minute | Standard Deviation 9.88 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Syanding HR, Visit 28 (Month 104), n=17 | 6.2 Beats per minute | Standard Deviation 11 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 29 (Month 108), n=13 | -0.2 Beats per minute | Standard Deviation 8.94 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 30 (Month 112), n=4 | 2.3 Beats per minute | Standard Deviation 12.84 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 31 (Month 116), n=3 | 7.3 Beats per minute | Standard Deviation 12.1 |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Visit 32 (Month 120), n=1 | 10.0 Beats per minute | — |
| Retigabine | Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position | Standing HR, Follow up, n=267 | 2.2 Beats per minute | Standard Deviation 11.39 |
Primary
Change From Baseline in Hematocrit
Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 2a (Month 4), n=79 | -0.012 Percentage of red blood cells in blood | Standard Deviation 0.023 |
| Retigabine | Change From Baseline in Hematocrit | Haematocrit, Visit 17 (Month 60), n=88 | 0.000 Percentage of red blood cells in blood | Standard Deviation 0.0314 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 21 (Month 76), n=39 | 0.010 Percentage of red blood cells in blood | Standard Deviation 0.0377 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 24 (Month 88), n=26 | 0.005 Percentage of red blood cells in blood | Standard Deviation 0.0294 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 1 (Month 1), n=340 | -0.009 Percentage of red blood cells in blood | Standard Deviation 0.0215 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 1a (Month 2), n=63 | -0.005 Percentage of red blood cells in blood | Standard Deviation 0.0227 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 2 (Month 3), n=308 | -0.004 Percentage of red blood cells in blood | Standard Deviation 0.0229 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 3 (Month 6), n=274 | -0.005 Percentage of red blood cells in blood | Standard Deviation 0.0244 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 3a (Month 8), n=95 | -0.009 Percentage of red blood cells in blood | Standard Deviation 0.0264 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 4 (Month 9), n=231 | -0.002 Percentage of red blood cells in blood | Standard Deviation 0.0263 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 4a (Month 10), n=111 | -0.004 Percentage of red blood cells in blood | Standard Deviation 0.0254 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 5 (Month 12), n=223 | -0.004 Percentage of red blood cells in blood | Standard Deviation 0.0256 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 6 (Month 16), n=196 | -0.003 Percentage of red blood cells in blood | Standard Deviation 0.027 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 7 (Month 20), n=166 | -0.001 Percentage of red blood cells in blood | Standard Deviation 0.0255 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 8 (Month 24), n=160 | 0.000 Percentage of red blood cells in blood | Standard Deviation 0.0275 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 9 (Month 28), n=141 | 0.005 Percentage of red blood cells in blood | Standard Deviation 0.026 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 10 (Month 32), n=122 | 0.004 Percentage of red blood cells in blood | Standard Deviation 0.0285 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 11 (Month 36), n=113 | -0.001 Percentage of red blood cells in blood | Standard Deviation 0.0301 |
| Retigabine | Change From Baseline in Hematocrit | Haematocrit, Visit 12 (Month 40), n=106 | 0.006 Percentage of red blood cells in blood | Standard Deviation 0.0301 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 13 (Month 44), n=95 | 0.003 Percentage of red blood cells in blood | Standard Deviation 0.0274 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 14 (Month 48), n=100 | -0.003 Percentage of red blood cells in blood | Standard Deviation 0.0286 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 15 (Month 52), n=88 | -0.001 Percentage of red blood cells in blood | Standard Deviation 0.0289 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 16 (Month 56), n=74 | -0.001 Percentage of red blood cells in blood | Standard Deviation 0.023 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 18 (Month 64), n=51 | 0.009 Percentage of red blood cells in blood | Standard Deviation 0.027 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 19 (Month 68), n=50 | 0.008 Percentage of red blood cells in blood | Standard Deviation 0.0278 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 20 (Month 72), n=55 | 0.004 Percentage of red blood cells in blood | Standard Deviation 0.0287 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 22 (Month 80), n=34 | 0.015 Percentage of red blood cells in blood | Standard Deviation 0.0303 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 23 (Month 84), n=30 | 0.000 Percentage of red blood cells in blood | Standard Deviation 0.0344 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 25 (Month 92), n=24 | 0.016 Percentage of red blood cells in blood | Standard Deviation 0.0264 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 26 (Month 96), n=24 | 0.013 Percentage of red blood cells in blood | Standard Deviation 0.0258 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 27 (Month 100), n=20 | 0.016 Percentage of red blood cells in blood | Standard Deviation 0.0201 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 28 (Month 104), n=16 | 0.016 Percentage of red blood cells in blood | Standard Deviation 0.0203 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 29 (Month 108), n=13 | -0.002 Percentage of red blood cells in blood | Standard Deviation 0.0268 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 30 (Month 112), n=4 | 0.000 Percentage of red blood cells in blood | Standard Deviation 0.0365 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 31 (Month 116), n=3 | 0.033 Percentage of red blood cells in blood | Standard Deviation 0.0666 |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit, Visit 32 (Month 120), n=1 | 0.080 Percentage of red blood cells in blood | — |
| Retigabine | Change From Baseline in Hematocrit | Hematocrit,Follow up, n=253 | 0.003 Percentage of red blood cells in blood | Standard Deviation 0.0262 |
Primary
Change From Baseline in Hematology Parameter Red Blood Cells (RBC)
The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 1 (Month 1), n=349 | -0.07 10^12 cells per liter | Standard Deviation 0.226 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 1a (Month 2), n=65 | 0.00 10^12 cells per liter | Standard Deviation 0.236 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 2 (Month 3), n=316 | -0.02 10^12 cells per liter | Standard Deviation 0.237 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 2a (Month 4), n=82 | -0.06 10^12 cells per liter | Standard Deviation 0.233 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 3 (Month 6), n=279 | -0.04 10^12 cells per liter | Standard Deviation 0.243 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 3a (Month 8), n=99 | -0.05 10^12 cells per liter | Standard Deviation 0.269 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 4 (Month 9), n=244 | -0.03 10^12 cells per liter | Standard Deviation 0.256 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 4a (Month 10), n=113 | -0.02 10^12 cells per liter | Standard Deviation 0.235 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 5 (Month 12), n=226 | -0.04 10^12 cells per liter | Standard Deviation 0.255 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 6 (Month 16), n=199 | -0.01 10^12 cells per liter | Standard Deviation 0.264 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 7 (Month 20), n=174 | -0.02 10^12 cells per liter | Standard Deviation 0.243 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 8 (Month 24), n=164 | -0.03 10^12 cells per liter | Standard Deviation 0.281 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 9 (Month 28), n=142 | 0.00 10^12 cells per liter | Standard Deviation 0.271 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 10 (Month 32), n=126 | -0.05 10^12 cells per liter | Standard Deviation 0.286 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 11 (Month 36), n=115 | -0.09 10^12 cells per liter | Standard Deviation 0.283 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 12 (Month 40), n=109 | -0.02 10^12 cells per liter | Standard Deviation 0.275 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 13 (Month 44), n=98 | -0.06 10^12 cells per liter | Standard Deviation 0.287 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 14 (Month 48), n=101 | -0.10 10^12 cells per liter | Standard Deviation 0.28 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 15 (Month 52), n=88 | -0.08 10^12 cells per liter | Standard Deviation 0.285 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 16 (Month 56), n=76 | -0.08 10^12 cells per liter | Standard Deviation 0.252 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 17 (Month 60), n=89 | -0.07 10^12 cells per liter | Standard Deviation 0.323 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 18 (Month 64), n=54 | -0.01 10^12 cells per liter | Standard Deviation 0.263 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 19 (Month 68), n=50 | 0.01 10^12 cells per liter | Standard Deviation 0.255 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 20 (Month 72), n=55 | -0.03 10^12 cells per liter | Standard Deviation 0.239 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 21 (Month 76), n=40 | 0.02 10^12 cells per liter | Standard Deviation 0.346 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 22 (Month 80), n=35 | 0.09 10^12 cells per liter | Standard Deviation 0.338 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 23 (Month 84), n=32 | 0.00 10^12 cells per liter | Standard Deviation 0.29 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 24 (Month 88), n=27 | 0.00 10^12 cells per liter | Standard Deviation 0.314 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 25 (Month 92), n=25 | 0.05 10^12 cells per liter | Standard Deviation 0.337 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 26 (Month 96), n=24 | 0.06 10^12 cells per liter | Standard Deviation 0.317 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 27 (Month 100), n=20 | 0.13 10^12 cells per liter | Standard Deviation 0.251 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 28 (Month 104), n=16 | 0.14 10^12 cells per liter | Standard Deviation 0.365 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 29 (Month 108), n=13 | -0.04 10^12 cells per liter | Standard Deviation 0.328 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 30 (Month 112), n=4 | 0.08 10^12 cells per liter | Standard Deviation 0.386 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 31 (Month 116), n=3 | 0.10 10^12 cells per liter | Standard Deviation 0.346 |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Visit 32 (Month 120), n=1 | 0.00 10^12 cells per liter | — |
| Retigabine | Change From Baseline in Hematology Parameter Red Blood Cells (RBC) | RBC, Follow up, n=256 | -0.01 10^12 cells per liter | Standard Deviation 0.263 |
Primary
Change From Baseline in Hemoglobin
The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 10 (Month 32), n=126 | 0.3 Grams per liter | Standard Deviation 9.58 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 17 (Month 60), n=89 | -2.4 Grams per liter | Standard Deviation 10.14 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 24 (Month 88), n=27 | -3.0 Grams per liter | Standard Deviation 9.46 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 29 (Month 108), n=13 | -8.1 Grams per liter | Standard Deviation 8.56 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 1 (Month 1), n=349 | -2.6 Grams per liter | Standard Deviation 6.96 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 1a (Month 2), n=65 | -1.8 Grams per liter | Standard Deviation 7.3 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 2 (Month 3), n=316 | -0.8 Grams per liter | Standard Deviation 7.89 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 2a (Month 4), n=82 | -3.3 Grams per liter | Standard Deviation 8.11 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 3 (Month 6), n=279 | -1.3 Grams per liter | Standard Deviation 8.21 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 3a (Month 8), n=99 | -3.0 Grams per liter | Standard Deviation 8.7 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 4 (Month 9), n=244 | -0.7 Grams per liter | Standard Deviation 8.87 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 4a (Month 10), n=113 | -2.0 Grams per liter | Standard Deviation 8.41 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 5 (Month 12), n=226 | -1.4 Grams per liter | Standard Deviation 8.64 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 6 (Month 16), n=199 | -0.4 Grams per liter | Standard Deviation 8.83 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 7 (Month 20), n=174 | -0.6 Grams per liter | Standard Deviation 9.01 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 8 (Month 24), n=164 | -0.3 Grams per liter | Standard Deviation 8.58 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 9 (Month 28), n=142 | 1.2 Grams per liter | Standard Deviation 8.99 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 11 (Month 36), n=115 | -1.0 Grams per liter | Standard Deviation 10.12 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 12 (Month 40), n=109 | 0.4 Grams per liter | Standard Deviation 9.78 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 13 (Month 44), n=98 | -0.1 Grams per liter | Standard Deviation 9.44 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 14 (Month 48), n=101 | -1.6 Grams per liter | Standard Deviation 9.57 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 15 (Month 52), n=88 | -1.6 Grams per liter | Standard Deviation 9.75 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 16 (Month 56), n=76 | -2.3 Grams per liter | Standard Deviation 7.47 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 18 (Month 64), n=54 | -1.1 Grams per liter | Standard Deviation 8.76 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 19 (Month 68), n=50 | -0.4 Grams per liter | Standard Deviation 9.42 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 20 (Month 72), n=55 | -2.5 Grams per liter | Standard Deviation 10.78 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 21 (Month 76), n=40 | -1.5 Grams per liter | Standard Deviation 11.67 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 22 (Month 80), n=35 | -0.8 Grams per liter | Standard Deviation 9.66 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 23 (Month 84), n=32 | -3.6 Grams per liter | Standard Deviation 11.61 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 25 (Month 92), n=25 | -2.3 Grams per liter | Standard Deviation 8.09 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 26 (Month 96), n=24 | -4.0 Grams per liter | Standard Deviation 8.26 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 27 (Month 100), n=20 | -2.8 Grams per liter | Standard Deviation 5.82 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 28 (Month 104), n=16 | -2.9 Grams per liter | Standard Deviation 9.54 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 30 (Month 112), n=4 | -12.5 Grams per liter | Standard Deviation 6.14 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 31 (Month 116), n=3 | 3.0 Grams per liter | Standard Deviation 22.52 |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Visit 32 (Month 120), n=1 | 25.0 Grams per liter | — |
| Retigabine | Change From Baseline in Hemoglobin | Hemoglobin, Follow up, n=256 | -0.1 Grams per liter | Standard Deviation 8.89 |
Primary
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume
The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 2 (Month 3), n=307 | 4.1 Milliliters | Standard Deviation 40.88 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Follow up, n=186 | -4.0 Milliliters | Standard Deviation 47.11 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 1 (Month 1), n=337 | 4.6 Milliliters | Standard Deviation 52.1 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 5 (Month 12), n=223 | 4.1 Milliliters | Standard Deviation 52.38 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 8 (Month 24), n=111 | 5.5 Milliliters | Standard Deviation 67.28 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 11 (Month 36), n=106 | 5.0 Milliliters | Standard Deviation 46.29 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 14 (Month 48), n=96 | -2.3 Milliliters | Standard Deviation 39.69 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 17 (Month 60), n=77 | 22.2 Milliliters | Standard Deviation 87.43 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 20 (Month 72), n=53 | 7.1 Milliliters | Standard Deviation 49.87 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 23 (Month 84), n=29 | 15.7 Milliliters | Standard Deviation 74.06 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 26 (Month 96), n=24 | 2.0 Milliliters | Standard Deviation 38.54 |
| Retigabine | Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume | PVR urine volume, Visit 29 (Month 108), n=10 | 21.9 Milliliters | Standard Deviation 63.58 |
Primary
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire
The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 20 (Month 72), n=47 | 3.07 Scores on a scale | Standard Deviation 16.172 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 26 (Month 96), n=24 | 4.07 Scores on a scale | Standard Deviation 11.745 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 14 (Month 48), n=83 | 0.78 Scores on a scale | Standard Deviation 13.976 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 17 (Month 60), n=68 | 2.37 Scores on a scale | Standard Deviation 15.197 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 23 (Month 84), n=26 | 4.31 Scores on a scale | Standard Deviation 13.849 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 29 (Month 108), n=12 | 6.35 Scores on a scale | Standard Deviation 14.783 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score Visit 32 (Month 120), n=1 | 14.36 Scores on a scale | — |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Follow up, n=224 | -0.83 Scores on a scale | Standard Deviation 14.256 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 2 (Month 3), n=296 | 1.33 Scores on a scale | Standard Deviation 14.409 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 3 (Month 6), n=262 | 0.87 Scores on a scale | Standard Deviation 14.618 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 4 (Month 9), n=229 | 0.27 Scores on a scale | Standard Deviation 14.365 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 5 (Month 12), n=214 | 1.24 Scores on a scale | Standard Deviation 14.498 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 8 (Month 24), n=142 | 3.76 Scores on a scale | Standard Deviation 12.406 |
| Retigabine | Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire | Final QOLIE-31-P Score, Visit 11 (Month 36), n=97 | 2.77 Scores on a scale | Standard Deviation 13.784 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position
Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 4 (Month 9), n=251 | 0.0 Millimeters of mercury | Standard Deviation 11.09 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 7 (Month 20), n=181 | 0.4 Millimeters of mercury | Standard Deviation 10.03 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 18 (Month 64), n=58 | 1.6 Millimeters of mercury | Standard Deviation 8.29 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 20 (Month 72), n=61 | 1.3 Millimeters of mercury | Standard Deviation 8.38 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 30 (Month 112), n=4 | 4.0 Millimeters of mercury | Standard Deviation 7.3 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 32 (Month 120), n=1 | -2.0 Millimeters of mercury | — |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 8 (Month 24), n=167 | 0.2 Millimeters of mercury | Standard Deviation 9.83 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 28 (Month 104), n=17 | 2.9 Millimeters of mercury | Standard Deviation 11.7 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 3 (Month 6), n=287 | -0.2 Millimeters of mercury | Standard Deviation 13.89 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 4 (Month 9), n=251 | -0.7 Millimeters of mercury | Standard Deviation 15.1 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 5 (Month 12), n=235 | -0.7 Millimeters of mercury | Standard Deviation 14.56 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 6 (Month 16), n=202 | -0.3 Millimeters of mercury | Standard Deviation 14.09 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 7 (Month 20), n=181 | -0.8 Millimeters of mercury | Standard Deviation 15.19 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 8 (Month 24), n=167 | -0.5 Millimeters of mercury | Standard Deviation 15.35 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 9 (Month 28), n=147 | -0.3 Millimeters of mercury | Standard Deviation 16.3 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 10 (Month 32), n=128 | -0.1 Millimeters of mercury | Standard Deviation 15.06 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 11 (Month 36), n=121 | 0.7 Millimeters of mercury | Standard Deviation 15.51 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 12 (Month 40), n=111 | 2.7 Millimeters of mercury | Standard Deviation 14.21 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 13 (Month 44), n=105 | -1.3 Millimeters of mercury | Standard Deviation 12.57 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 14 (Month 48), n=104 | -1.6 Millimeters of mercury | Standard Deviation 14.67 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 15 (Month 52), n=91 | -1.2 Millimeters of mercury | Standard Deviation 14.35 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 16 (Month 56), n=77 | 0.9 Millimeters of mercury | Standard Deviation 15.04 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 17 (Month 60), n=92 | -0.7 Millimeters of mercury | Standard Deviation 14.92 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 18 (Month 64), n= 58 | 0.6 Millimeters of mercury | Standard Deviation 12.84 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 19 (Month 68), n=53 | 0.2 Millimeters of mercury | Standard Deviation 11.85 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 20 (Month 72), n=61 | 0.5 Millimeters of mercury | Standard Deviation 12.43 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 21 (Month 76), n=43 | 3.5 Millimeters of mercury | Standard Deviation 12.47 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 22 (Month 80), n=37 | 0.9 Millimeters of mercury | Standard Deviation 14.31 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 23 (Month 84), n=32 | -0.8 Millimeters of mercury | Standard Deviation 14.85 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 24 (Month 88), n=29 | -0.6 Millimeters of mercury | Standard Deviation 13.28 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 25 (Month 92), n=25 | -1.6 Millimeters of mercury | Standard Deviation 10.49 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 1 (Month 1), n=358 | 0.4 Millimeters of mercury | Standard Deviation 10.05 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 2 (Month 3), n=328 | 0.3 Millimeters of mercury | Standard Deviation 9.83 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 3 (Month 6), n=287 | -0.2 Millimeters of mercury | Standard Deviation 10.19 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 5 (Month 12), n=235 | 0.7 Millimeters of mercury | Standard Deviation 10.79 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 6 (Month 16), n=202 | 1.0 Millimeters of mercury | Standard Deviation 10.02 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 8 (Month 24), n=167 | 0.4 Millimeters of mercury | Standard Deviation 10.63 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 9 (Month 28), n=147 | 1.5 Millimeters of mercury | Standard Deviation 10.62 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 10 (Month 32), n=128 | 0.0 Millimeters of mercury | Standard Deviation 10.42 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 11 (Month 36), n=121 | 1.0 Millimeters of mercury | Standard Deviation 10.65 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP,Visit 12 (Month 40), n=112 | 2.0 Millimeters of mercury | Standard Deviation 10.37 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 13 (Month 44), n=105 | 0.5 Millimeters of mercury | Standard Deviation 9.54 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 14 (Month 48), n=104 | 0.0 Millimeters of mercury | Standard Deviation 10.3 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 15 (Month 52), n=91 | 0.1 Millimeters of mercury | Standard Deviation 11.1 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 16 (Month 56), n=77 | 1.2 Millimeters of mercury | Standard Deviation 9.68 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 17 (Month 60), n=92 | -1.0 Millimeters of mercury | Standard Deviation 11.08 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 19 (Month 68), n=53 | 0.6 Millimeters of mercury | Standard Deviation 8.66 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 21 (Month 76), n=43 | 3.2 Millimeters of mercury | Standard Deviation 8.88 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 22 (Month 80), n=37 | 1.8 Millimeters of mercury | Standard Deviation 7.66 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 23 (Month 84), n=32 | -1.4 Millimeters of mercury | Standard Deviation 8.64 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 24 (Month 88), n=29 | 3.4 Millimeters of mercury | Standard Deviation 8.83 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 25 (Month 92), n=25 | 2.3 Millimeters of mercury | Standard Deviation 7.29 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 26 (Month 96), n=26 | 1.5 Millimeters of mercury | Standard Deviation 10.1 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 27 (Month 100), n=20 | 1.5 Millimeters of mercury | Standard Deviation 8.42 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 28 (Month 104), n=17 | 3.4 Millimeters of mercury | Standard Deviation 10.56 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 29 (Month 108), n=13 | 0.5 Millimeters of mercury | Standard Deviation 6.74 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Visit 31 (Month 116), n=3 | 11.0 Millimeters of mercury | Standard Deviation 7.55 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine DBP, Follow up, n=267 | 1.3 Millimeters of mercury | Standard Deviation 10.08 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 1 (Month 1), n=357 | 0.6 Millimeters of mercury | Standard Deviation 10.68 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 2 (Month 3), n=328 | 0.2 Millimeters of mercury | Standard Deviation 10.62 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 3 (Month 6), n=287 | -0.1 Millimeters of mercury | Standard Deviation 10.21 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 4 (Month 9), n=251 | 0.2 Millimeters of mercury | Standard Deviation 10.14 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 5 (Month 12), n=235 | 0.8 Millimeters of mercury | Standard Deviation 10.17 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 6 (Month 16), n=202 | 0.3 Millimeters of mercury | Standard Deviation 10.16 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 7 (Month 20), n=181 | 0.4 Millimeters of mercury | Standard Deviation 9.51 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 9 (Month 28), n=147 | 0.3 Millimeters of mercury | Standard Deviation 10 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 10 (Month 32), n=128 | -0.6 Millimeters of mercury | Standard Deviation 10.64 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 11 (Month 36), n=121 | 0.9 Millimeters of mercury | Standard Deviation 10.94 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 12 (Month 40), n=111 | 1.4 Millimeters of mercury | Standard Deviation 11.01 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 13 (Month 44), n=105 | -0.2 Millimeters of mercury | Standard Deviation 10.76 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 14 (Month 48), n=104 | 0.3 Millimeters of mercury | Standard Deviation 10.35 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 15 (Month 52), n=91 | -1.5 Millimeters of mercury | Standard Deviation 11 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 16 (Month 56), n=77 | -0.3 Millimeters of mercury | Standard Deviation 10.4 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 17 (Month 60), n=92 | -1.5 Millimeters of mercury | Standard Deviation 9.7 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 18 (Month 64), n=58 | 0.5 Millimeters of mercury | Standard Deviation 8.07 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 19 (Month 68), n=53 | 0.0 Millimeters of mercury | Standard Deviation 7.2 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 20 (Month 72), n=61 | 0.3 Millimeters of mercury | Standard Deviation 8.31 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 21 (Month 76), n=43 | 1.4 Millimeters of mercury | Standard Deviation 8.93 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 22 (Month 80), n=37 | 0.3 Millimeters of mercury | Standard Deviation 8.03 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 23 (Month 84), n=32 | -0.4 Millimeters of mercury | Standard Deviation 7.98 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 24 (Month 88), n=29 | 1.6 Millimeters of mercury | Standard Deviation 8.38 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 25 (Month 92), n=25 | 1.0 Millimeters of mercury | Standard Deviation 7.33 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 26 (Month 96), n=26 | 1.6 Millimeters of mercury | Standard Deviation 9.2 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 27 (Month 100), n=20 | 0.2 Millimeters of mercury | Standard Deviation 10.48 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 28 (Month 104), n=17 | 2.8 Millimeters of mercury | Standard Deviation 11.65 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 29 (Month 108), n=13 | -0.5 Millimeters of mercury | Standard Deviation 9.42 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 30 (Month 112), n=4 | 1.3 Millimeters of mercury | Standard Deviation 9.18 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 31 (Month 116), n=3 | 8.0 Millimeters of mercury | Standard Deviation 11.79 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Visit 32 (Month 120), n=1 | -1.0 Millimeters of mercury | — |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing DBP, Follow up, n=267 | 2.0 Millimeters of mercury | Standard Deviation 10.57 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 1 (Month 1), n=358 | -0.2 Millimeters of mercury | Standard Deviation 12.03 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 2 (Month 3), n=328 | -0.4 Millimeters of mercury | Standard Deviation 12.09 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 3 (Month 6), n=287 | 0.5 Millimeters of mercury | Standard Deviation 13.53 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 4 (Month 9), n=251 | 0.0 Millimeters of mercury | Standard Deviation 15.32 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 5 (Month 12), n=235 | 0.5 Millimeters of mercury | Standard Deviation 12.99 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 6 (Month 16), n=202 | 0.7 Millimeters of mercury | Standard Deviation 14.39 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 7 (Month 20), n=181 | -0.5 Millimeters of mercury | Standard Deviation 14.34 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 8 (Month 24), n=167 | -0.4 Millimeters of mercury | Standard Deviation 14.11 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 9 (Month 28), n=147 | 0.2 Millimeters of mercury | Standard Deviation 13.78 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 10 (Month 32), n=128 | 0.3 Millimeters of mercury | Standard Deviation 13.6 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 11 (Month 36), n=121 | 0.2 Millimeters of mercury | Standard Deviation 14.9 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 12 (Month 40), n=112 | 1.3 Millimeters of mercury | Standard Deviation 13.9 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 13 (Month 44), n=105 | 0.1 Millimeters of mercury | Standard Deviation 11.28 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 14 (Month 48), n=104 | -1.1 Millimeters of mercury | Standard Deviation 13.03 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 15 (Month 52), n=91 | -0.7 Millimeters of mercury | Standard Deviation 14.05 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 16 (Month 56), n=77 | 2.6 Millimeters of mercury | Standard Deviation 13.41 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 17 (Month 60), n=92 | -0.2 Millimeters of mercury | Standard Deviation 14.48 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 18 (Month 64), n=58 | 1.8 Millimeters of mercury | Standard Deviation 12.11 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 19 (Month 68), n=53 | 1.1 Millimeters of mercury | Standard Deviation 13 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 20 (Month 72), n=61 | 2.5 Millimeters of mercury | Standard Deviation 10.26 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 21 (Month 76), n=43 | 4.4 Millimeters of mercury | Standard Deviation 15.51 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 22 (Month 80), n=37 | 2.3 Millimeters of mercury | Standard Deviation 15.13 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 23 (Month 84), n=32 | 1.1 Millimeters of mercury | Standard Deviation 13.9 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 24 (Month 88), n=29 | 2.7 Millimeters of mercury | Standard Deviation 12.51 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 25 (Month 92), n=25 | 2.8 Millimeters of mercury | Standard Deviation 10.44 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 26 (Month 96), n=26 | 2.9 Millimeters of mercury | Standard Deviation 14.66 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 27 (Month 100), n=20 | 2.6 Millimeters of mercury | Standard Deviation 10.61 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 28 (Month 104), n=17 | 5.8 Millimeters of mercury | Standard Deviation 10.91 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 29 (Month 108), n=13 | -2.2 Millimeters of mercury | Standard Deviation 8.68 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 30 (Month 112), n=4 | 8.5 Millimeters of mercury | Standard Deviation 6.95 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 31 (Month 116), n=3 | 13.7 Millimeters of mercury | Standard Deviation 4.93 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Visit 32 (Month 120), n=1 | 11.0 Millimeters of mercury | — |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Supine SBP, Follow up, n=267 | 1.2 Millimeters of mercury | Standard Deviation 14.15 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 1 (Month 1), n=357 | -1.2 Millimeters of mercury | Standard Deviation 12.2 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 2 (Month 3), n=328 | -0.7 Millimeters of mercury | Standard Deviation 13.3 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 26 (Month 96), n=26 | -0.2 Millimeters of mercury | Standard Deviation 14.68 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 27 (Month 100), n=20 | 0.0 Millimeters of mercury | Standard Deviation 12.62 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 29 (Month 108), n=13 | -2.2 Millimeters of mercury | Standard Deviation 10.58 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 30 (Month 112), n=4 | 1.8 Millimeters of mercury | Standard Deviation 9.6 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 31 (Month 116), n=3 | 9.0 Millimeters of mercury | Standard Deviation 1 |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Visit 32 (Month 120), n=1 | 10.0 Millimeters of mercury | — |
| Retigabine | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position | Standing SBP, Follow up, n=267 | 1.4 Millimeters of mercury | Standard Deviation 14.59 |
Primary
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index)
AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 5 (Month 12), n=228 | -0.5 Scores on a scale | Standard Deviation 3.58 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 17 (Month 60), n=87 | -0.4 Scores on a scale | Standard Deviation 5.02 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 1 (Month 1), n=348 | -0.4 Scores on a scale | Standard Deviation 3.82 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 2 (Month 3), n=325 | -0.5 Scores on a scale | Standard Deviation 3.8 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 8 (Month 24), n=114 | -0.5 Scores on a scale | Standard Deviation 3.84 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 11 (Month 36), n=115 | -0.3 Scores on a scale | Standard Deviation 5.22 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 14 (Month 48), n=102 | -0.6 Scores on a scale | Standard Deviation 4.89 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 20 (Month 72), n=56 | -0.1 Scores on a scale | Standard Deviation 5.52 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 23 (Month 84), n=32 | 0.8 Scores on a scale | Standard Deviation 6.61 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 26 (Month 96), n=26 | 0.5 Scores on a scale | Standard Deviation 5.58 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 29 (Month 108), n=13 | 0.0 Scores on a scale | Standard Deviation 1.68 |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Visit 32 (Month 120), n=1 | 0.0 Scores on a scale | — |
| Retigabine | Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) | AUA Overall Score, Follow up, n=217 | 0.0 Scores on a scale | Standard Deviation 4.43 |
Primary
Change From Baseline in Total Protein
Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 11 (Month 36), n=116 | -2.1 Grams per liter | Standard Deviation 4.35 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 15 (Month 52), n=88 | -1.9 Grams per liter | Standard Deviation 4.81 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 16 (Month 56), n=76 | -2.1 Grams per liter | Standard Deviation 4.18 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 17 (Month 60), n=90 | -2.4 Grams per liter | Standard Deviation 4.29 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 18 (Month 64), n=55 | -2.2 Grams per liter | Standard Deviation 4.12 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 19 (Month 68), n=50 | -2.2 Grams per liter | Standard Deviation 3.95 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 23 (Month 84), n=32 | -2.2 Grams per liter | Standard Deviation 4.38 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 24 (Month 88), n=28 | -1.9 Grams per liter | Standard Deviation 4.63 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 30 (Month 112), n=4 | 0.8 Grams per liter | Standard Deviation 2.36 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 1 (Month 1), n=352 | -1.1 Grams per liter | Standard Deviation 4.32 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 1a (Month 2), n=1 | -12.0 Grams per liter | — |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 2 (Month 3), n=322 | -0.8 Grams per liter | Standard Deviation 4.34 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 2a (Month 4), n=1 | -3.0 Grams per liter | — |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 3 (Month 6), n=279 | -1.1 Grams per liter | Standard Deviation 4.18 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 4 (Month 9), n=248 | -1.8 Grams per liter | Standard Deviation 5.42 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 5 (Month 12), n=228 | -1.6 Grams per liter | Standard Deviation 4.34 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 6 (Month 16), n=200 | -1.3 Grams per liter | Standard Deviation 4.24 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 7 (Month 20), n=176 | -1.8 Grams per liter | Standard Deviation 4.19 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 8 (Month 24), n=163 | -1.5 Grams per liter | Standard Deviation 4.25 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 9 (Month 28), n=142 | -1.5 Grams per liter | Standard Deviation 4.22 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 10 (Month 32), n=126 | -1.3 Grams per liter | Standard Deviation 4.62 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 12 (Month 40), n=108 | -1.9 Grams per liter | Standard Deviation 4.36 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 13 (Month 44), n=101 | -1.8 Grams per liter | Standard Deviation 4.1 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 14 (Month 48), n=101 | -2.0 Grams per liter | Standard Deviation 4.37 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 20 (Month 72), n=58 | -3.0 Grams per liter | Standard Deviation 4.85 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 21 (Month 76), n=40 | -1.8 Grams per liter | Standard Deviation 4.01 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 22 (Month 80), n=35 | -0.6 Grams per liter | Standard Deviation 5.09 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 25 (Month 92), n=25 | -1.2 Grams per liter | Standard Deviation 4.82 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 26 (Month 96), n=26 | -1.1 Grams per liter | Standard Deviation 5.32 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 27 (Month 100), n=20 | -0.9 Grams per liter | Standard Deviation 4.08 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 28 (Month 104), n=16 | -0.2 Grams per liter | Standard Deviation 4.68 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 29 (Month 108), n=13 | -2.1 Grams per liter | Standard Deviation 4.57 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 31 (Month 116), n=3 | -4.7 Grams per liter | Standard Deviation 0.58 |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Visit 32 (Month 120), n=1 | -4.0 Grams per liter | — |
| Retigabine | Change From Baseline in Total Protein | Total Protein, Follow up, n=261 | -1.1 Grams per liter | Standard Deviation 4.75 |
Primary
Change From Baseline in Urine Potential of Hydrogen (pH)
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 5 (Month 12), n=222 | -0.02 Points on a scale | Standard Deviation 0.616 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 7 (Month 20), n=170 | 0.04 Points on a scale | Standard Deviation 0.686 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 11 (Month 36), n=111 | 0.26 Points on a scale | Standard Deviation 0.663 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 26 (Month 96), n=26 | 0.21 Points on a scale | Standard Deviation 0.551 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 1 (Month 1), n=349 | -0.13 Points on a scale | Standard Deviation 0.685 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 1a (Month 2), n=1 | 0.50 Points on a scale | — |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 2 (Month 3), n=313 | -0.09 Points on a scale | Standard Deviation 0.699 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 17 (Month 60), n=84 | 0.32 Points on a scale | Standard Deviation 0.662 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 3 (Month 6), n=270 | -0.07 Points on a scale | Standard Deviation 0.634 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 4 (Month 9), n=245 | 0.02 Points on a scale | Standard Deviation 0.633 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 6 (Month 16), n=196 | 0.07 Points on a scale | Standard Deviation 0.651 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 8 (Month 24), n=158 | 0.09 Points on a scale | Standard Deviation 0.672 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 9 (Month 28), n=138 | 0.17 Points on a scale | Standard Deviation 0.787 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 10 (Month 32), n=124 | 0.17 Points on a scale | Standard Deviation 0.715 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 12 (Month 40), n=107 | 0.30 Points on a scale | Standard Deviation 0.7 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 13 (Month 44), n=97 | 0.36 Points on a scale | Standard Deviation 0.736 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 14 (Month 48), n=99 | 0.38 Points on a scale | Standard Deviation 0.722 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 15 (Month 52), n=83 | 0.27 Points on a scale | Standard Deviation 0.621 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 16 (Month 56), n=71 | 0.34 Points on a scale | Standard Deviation 0.84 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 18 (Month 64), n=53 | 0.33 Points on a scale | Standard Deviation 0.627 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 19 (Month 68), n=50 | 0.42 Points on a scale | Standard Deviation 0.785 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 20 (Month 72), n=55 | 0.27 Points on a scale | Standard Deviation 0.686 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 21 (Month 76), n=39 | 0.36 Points on a scale | Standard Deviation 0.688 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 22 (Month 80), n=35 | 0.23 Points on a scale | Standard Deviation 0.657 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 23 (Month 84), n=31 | 0.35 Points on a scale | Standard Deviation 0.661 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 24 (Month 88), n=28 | 0.29 Points on a scale | Standard Deviation 0.517 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 25 (Month 92), n=25 | 0.36 Points on a scale | Standard Deviation 0.621 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 27 (Month 100), n=20 | 0.45 Points on a scale | Standard Deviation 0.724 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 28 (Month 104), n=16 | 0.13 Points on a scale | Standard Deviation 0.342 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 29 (Month 108), n=13 | 0.77 Points on a scale | Standard Deviation 0.753 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 30 (Month 112), n=4 | 0.50 Points on a scale | Standard Deviation 0.577 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 31 (Month 116), n=3 | -0.17 Points on a scale | Standard Deviation 0.764 |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Visit 32 (Month 120), n=1 | 0.00 Points on a scale | — |
| Retigabine | Change From Baseline in Urine Potential of Hydrogen (pH) | pH, Follow up, n=248 | 0.22 Points on a scale | Standard Deviation 0.746 |
Primary
Change From Baseline in Urine Specific Gravity
Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 7 (Month 20), n=170 | 0.0015 Ratio | Standard Deviation 0.00901 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Follow up, n=247 | 0.0008 Ratio | Standard Deviation 0.00889 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 4 (Month 9), n=243 | 0.0002 Ratio | Standard Deviation 0.00984 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 1 (Month 1), n=348 | -0.0011 Ratio | Standard Deviation 0.00936 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 1a (Month 2), n=1 | 0.0000 Ratio | — |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 2 (Month 3), n=312 | -0.0011 Ratio | Standard Deviation 0.00918 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 3 (Month 6), n=270 | 0.0003 Ratio | Standard Deviation 0.00896 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 5 (Month 12), n=221 | -0.0010 Ratio | Standard Deviation 0.01014 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 6 (Month 16), n=196 | 0.0006 Ratio | Standard Deviation 0.01016 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 8 (Month 24), n=157 | 0.0002 Ratio | Standard Deviation 0.01015 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 9 (Month 28), n=137 | 0.0007 Ratio | Standard Deviation 0.00922 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 10 (Month 32), n=124 | 0.0001 Ratio | Standard Deviation 0.00986 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 11 (Month 36), n=111 | -0.0016 Ratio | Standard Deviation 0.01058 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 12 (Month 40), n=106 | 0.0004 Ratio | Standard Deviation 0.01007 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 13 (Month 44), n=97 | 0.0004 Ratio | Standard Deviation 0.00944 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 14 (Month 48), n=99 | 0.0000 Ratio | Standard Deviation 0.01019 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 15 (Month 52), n=83 | -0.0100 Ratio | Standard Deviation 0.10022 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 16 (Month 56), n=71 | 0.0003 Ratio | Standard Deviation 0.01089 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 17 (Month 60), n=84 | -0.0008 Ratio | Standard Deviation 0.01022 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 18 (Month 64), n=53 | 0.0006 Ratio | Standard Deviation 0.00894 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 19 (Month 68), n=50 | 0.0014 Ratio | Standard Deviation 0.01052 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 20 (Month 72), n=55 | -0.0021 Ratio | Standard Deviation 0.00882 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 21 (Month 76), n=39 | 0.0030 Ratio | Standard Deviation 0.00837 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 22 (Month 80), n=35 | 0.0015 Ratio | Standard Deviation 0.00939 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 23 (Month 84), n=31 | 0.0024 Ratio | Standard Deviation 0.00917 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 24 (Month 88), n=28 | 0.0043 Ratio | Standard Deviation 0.00994 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 25 (Month 92), n=25 | 0.0046 Ratio | Standard Deviation 0.00861 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 26 (Month 96), n=26 | 0.0035 Ratio | Standard Deviation 0.00857 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 27 (Month 100), n=20 | 0.0029 Ratio | Standard Deviation 0.00718 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 28 (Month 104), n=16 | 0.0026 Ratio | Standard Deviation 0.00713 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 29 (Month 108), n=13 | 0.0020 Ratio | Standard Deviation 0.00709 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 30 (Month 112), n=4 | 0.0020 Ratio | Standard Deviation 0.00673 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 31 (Month 116), n=3 | 0.0030 Ratio | Standard Deviation 0.01082 |
| Retigabine | Change From Baseline in Urine Specific Gravity | Specific gravity, Visit 32 (Month 120), n=1 | -0.0010 Ratio | — |
Primary
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug
Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles).
Time frame: Up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 45, n=337 | 10.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 91, n=316 | 16.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 104, n=308 | 18.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 141, n=292 | 22.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 164, n=288 | 23.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 492, n=197 | 47.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 703, n=164 | 56.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 720, n=160 | 57.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 938, n=131 | 65.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 980, n=125 | 66.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1541, n=96 | 73.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1563, n=93 | 74.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1931, n=58 | 78.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2296, n=41 | 83.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2317, n=40 | 84.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2537, n=29 | 88.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2772, n=26 | 89.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2793, n=25 | 89.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 0, n=374 | 0.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1, n=371 | 1.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2, n=369 | 1.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3, n=368 | 2.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 4, n=367 | 2.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 5, n=366 | 2.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 6, n=365 | 2.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 11, n=364 | 3.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 13, n=363 | 3.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 14, n=362 | 3.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 16, n=361 | 4.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 21, n=360 | 4.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 22, n=359 | 4.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 27, n=356 | 5.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 28, n=350 | 6.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 29, n=348 | 7.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 30, n=344 | 8.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 32, n=343 | 8.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 35, n=341 | 9.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 40, n=340 | 9.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 41, n=339 | 9.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 42, n=338 | 10.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 50, n=336 | 10.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 56, n=335 | 10.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 61, n=334 | 11.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 62, n=333 | 11.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 63, n=331 | 12.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 71, n=330 | 12.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 77, n=329 | 12.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 82, n=328 | 12.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 85, n=326 | 13.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 86, n=325 | 13.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 88, n=324 | 13.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 90, n=322 | 14.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 92, n=313 | 16.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 94, n=312 | 17.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 95, n=310 | 17.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 99, n=309 | 17.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 105, n=307 | 18.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 107, n=306 | 18.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 110, n=305 | 18.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 112, n=303 | 19.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 118, n=302 | 19.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 121, n=300 | 20.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 122, n=299 | 20.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 126, n=298 | 20.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 132, n=297 | 21.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 134, n=296 | 21.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 135, n=295 | 21.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 138, n=294 | 21.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 139, n=293 | 22.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 152, n=291 | 22.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 155, n=290 | 22.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 161, n=289 | 23.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 172, n=287 | 23.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 176, n=286 | 23.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 179, n=282 | 25.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 180, n=278 | 26.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 181, n=275 | 26.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 182, n=273 | 27.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 183, n=272 | 27.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 184, n=271 | 27.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 187, n=270 | 28.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 188, n=269 | 28.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 189, n=268 | 28.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 192, n=267 | 29.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 195, n=265 | 29.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 198, n=264 | 29.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 199, n=263 | 30.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 204, n=262 | 30.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 214, n=261 | 30.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 216, n=260 | 30.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 218, n=259 | 31.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 221, n=258 | 31.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 228, n=257 | 31.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 231, n=256 | 31.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 233, n=255 | 32.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 235, n=254 | 32.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 236, n=253 | 32.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 237, n=251 | 33.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 252, n=250 | 33.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 260, n=249 | 33.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 264, n=248 | 34.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 265, n=247 | 34.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 269, n=246 | 34.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 270, n=245 | 34.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 272, n=240 | 36.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 274, n=239 | 36.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 275, n=238 | 36.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 276, n=236 | 37.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 278, n=235 | 37.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 279, n=234 | 37.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 292, n=233 | 38.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 299, n=231 | 38.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 301, n=230 | 38.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 310, n=229 | 39.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 315, n=228 | 39.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 316, n=227 | 39.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 317, n=226 | 39.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 322, n=225 | 40.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 325, n=224 | 40.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 339, n=223 | 40.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 351, n=222 | 41.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 357, n=221 | 41.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 358, n=219 | 41.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 363, n=218 | 42.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 372, n=217 | 42.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 375, n=216 | 42.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 377, n=215 | 42.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 416, n=214 | 43.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 419, n=213 | 43.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 425, n=212 | 43.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 429, n=211 | 43.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 437, n=210 | 44.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 447, n=209 | 44.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 455, n=208 | 44.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 458, n=207 | 44.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 460, n=206 | 45.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 461, n=205 | 45.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 478, n=204 | 45.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 480, n=203 | 46.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 482, n=202 | 46.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 485, n=200 | 46.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 493, n=196 | 47.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 497, n=194 | 48.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 498, n=193 | 48.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 501, n=192 | 48.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 523, n=191 | 49.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 525, n=190 | 49.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 534, n=189 | 49.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 536, n=188 | 50.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 541, n=187 | 50.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 553, n=186 | 50.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 556, n=185 | 50.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 587, n=184 | 51.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 593, n=183 | 51.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 594, n=182 | 51.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 596, n=181 | 51.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 601, n=180 | 52.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 602, n=178 | 52.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 610, n=177 | 52.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 612, n=176 | 53.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 617, n=175 | 53.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 618, n=174 | 53.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 632, n=173 | 54.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 635, n=172 | 54.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 669, n=171 | 54.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 676, n=170 | 54.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 678, n=169 | 55.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 685, n=168 | 55.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 700, n=167 | 55.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 702, n=165 | 56.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 707, n=163 | 56.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 714, n=162 | 56.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 719, n=161 | 57.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 721, n=159 | 57.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 724, n=158 | 58.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 729, n=157 | 58.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 760, n=156 | 58.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 775, n=155 | 58.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 777, n=154 | 59.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 778, n=153 | 59.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 779, n=152 | 59.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 781, n=151 | 59.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 796, n=150 | 60.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 803, n=149 | 60.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 818, n=148 | 60.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 835, n=147 | 60.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 840, n=146 | 61.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 841, n=144 | 61.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 842, n=143 | 62.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 844, n=142 | 62.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 845, n=141 | 62.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 855, n=140 | 62.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 856, n=139 | 63.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 863, n=138 | 63.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 870, n=137 | 63.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 884, n=136 | 63.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 893, n=135 | 64.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 904, n=134 | 64.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 924, n=133 | 64.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 927, n=132 | 64.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 944, n=130 | 65.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 947, n=128 | 66.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 952, n=127 | 66.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 975, n=126 | 66.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 994, n=123 | 67.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1067, n=122 | 67.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1074, n=121 | 67.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1084, n=120 | 68.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1091, n=119 | 68.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1129, n=118 | 68.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1141, n=117 | 68.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1142, n=116 | 69.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1148, n=115 | 69.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1196, n=114 | 69.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1198, n=113 | 69.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1206, n=112 | 70.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1207, n=111 | 70.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1211, n=110 | 70.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1221, n=109 | 71.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1231, n=108 | 71.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1299, n=107 | 71.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1316, n=106 | 71.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1322, n=105 | 72.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1389, n=104 | 72.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1413, n=103 | 72.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1436, n=102 | 72.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1446, n=101 | 72.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1450, n=100 | 73.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1451, n=99 | 73.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1452, n=98 | 73.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1521, n=97 | 73.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1545, n=95 | 73.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1547, n=94 | 74.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1567, n=92 | 74.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1569, n=91 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1589, n=90 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1618, n=89 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1619, n=88 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1623, n=87 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1632, n=86 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1656, n=85 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1660, n=84 | 74.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1668, n=83 | 74.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1672, n=82 | 75.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1676, n=81 | 75.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1680, n=80 | 75.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1694, n=79 | 75.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1697, n=78 | 75.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1752, n=77 | 75.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1756, n=76 | 75.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1760, n=75 | 75.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1792, n=74 | 76.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1802, n=73 | 76.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1807, n=72 | 76.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1814, n=71 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1819, n=70 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1836, n=69 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1849, n=68 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1855, n=67 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1887, n=66 | 76.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1895, n=65 | 76.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1904, n=64 | 76.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1919, n=63 | 76.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1920, n=62 | 77.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1926, n=61 | 77.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1928, n=60 | 77.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1929, n=59 | 77.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1937, n=57 | 78.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 1951, n=56 | 78.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2005, n=55 | 79.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2037, n=54 | 79.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2044, n=53 | 79.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2092, n=52 | 79.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2157, n=51 | 80.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2161, n=50 | 80.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2162, n=49 | 81.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2182, n=48 | 81.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2183, n=47 | 81.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2184, n=46 | 82.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2227, n=45 | 82.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2281, n=44 | 82.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2283, n=43 | 83.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2285, n=42 | 83.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2380, n=39 | 84.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2395, n=37 | 85.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2400, n=36 | 85.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2405, n=35 | 86.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2408, n=34 | 86.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2415, n=33 | 86.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2443, n=32 | 86.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2525, n=31 | 87.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2533, n=30 | 87.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2639, n=28 | 88.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2664, n=27 | 88.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2829, n=24 | 90.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2870, n=23 | 90.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2884, n=22 | 91.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2973, n=21 | 91.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2975, n=20 | 91.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 2998, n=19 | 92.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3101, n=18 | 92.6 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3118, n=17 | 93.0 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3137, n=16 | 93.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3144, n=15 | 93.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3147, n=14 | 94.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3185, n=13 | 94.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3220, n=11 | 95.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3231, n=10 | 95.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3243, n=9 | 96.3 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3246, n=8 | 96.7 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3276, n=7 | 97.1 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3277, n=6 | 97.5 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3285, n=5 | 97.9 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3318, n=4 | 98.4 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3360, n=3 | 98.8 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3483, n=2 | 99.2 Percentage Probability of disc. |
| Retigabine | Kaplan-Meier Estimate of the Probability of Disc. From Study Drug | Day 3582, n=1 | 99.6 Percentage Probability of disc. |
Primary
Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment disc. up to 122 months have been presented.
Time frame: Up to 122 months
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine | Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.) | 115 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after Retigabine dose in this study and on or before 30 days after the last Retigabine dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study.
Time frame: Up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Any TEAE | 324 Participants |
| Retigabine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Any TESAE | 78 Participants |
Primary
Percentage of Participants With Abnormal Results of Neurological Examination
A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed.
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 2 (Month 3), A-NCS, n=328 | 23 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 12 (Month 40), A-CS, n=112 | 10 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 13 (Month 44), A-NCS, n=105 | 31 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 15 (Month 52), A-CS, n=91 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 17 (Month 60), A-CS, n=89 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 1 (Month 1), A-NCS, n=356 | 23 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 1 (Month 1), A-CS, n=356 | 10 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 2 (Month 3), A-CS, n=328 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 3 (Month 6), A-NCS, n=287 | 22 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 3 (Month 6), A-CS, n=287 | 10 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 4 (Month 9), A-NCS, n=252 | 23 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 4 (Month 9), A-CS, n=252 | 11 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 5 (Month 12), A-NCS, n=234 | 27 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 5 (Month 12), A-CS, n=234 | 12 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 6 (Month 16), A-NCS, n=202 | 24 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 6 (Month 16), A-CS, n=202 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 7 (Month 20), A-NCS, n=179 | 25 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 7 (Month 20), A-CS, n=179 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 8 (Month 24), A-NCS, n=166 | 34 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 8 (Month 24), A-CS, n=166 | 10 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 9 (Month 28), A-NCS, n=146 | 32 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 9 (Month 28), A-CS, n=146 | 8 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 10 (Month 32), A-NCS, n=127 | 32 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 10 (Month 32), A-CS, n=127 | 8 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 11 (Month 36), A-NCS, n=121 | 35 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 11 (Month 36), A-CS, n=121 | 8 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 12 (Month 40), A-NCS, n=112 | 28 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 13 (Month 44), A-CS, n=105 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 14 (Month 48), A-NCS, n=104 | 28 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 14 (Month 48), A-CS, n=104 | 11 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 15 (Month 52), A-NCS, n=91 | 31 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 16 (Month 56), A-NCS, n=77 | 32 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 16 (Month 56), A-CS, n=77 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 17 (Month 60), A-NCS, n=89 | 29 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 18 (Month 64), A-NCS, n=58 | 29 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 18 (Month 64), A-CS, n=58 | 10 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 19 (Month 68), A-NCS, n=53 | 36 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 19 (Month 68), A-CS, n=53 | 9 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 20 (Month 72), A-NCS, n=59 | 41 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 20 (Month 72), A-CS, n=59 | 7 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 21 (Month 76), A-NCS, n=43 | 40 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 21 (Month 76), A-CS, n=43 | 7 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 22 (Month 80), A-NCS, n=37 | 41 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 22 (Month 80), A-CS, n=37 | 5 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 23 (Month 84), A-NCS, n=32 | 47 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 23 (Month 84), A-CS, n=32 | 3 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 24 (Month 88), A-NCS, n=29 | 45 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 24 (Month 88), A-CS, n=29 | 7 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 25 (Month 92), A-NCS, n=25 | 40 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 25 (Month 92), A-CS, n=25 | 8 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 26 (Month 96), A-NCS, n=26 | 42 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 26 (Month 96), A-CS, n=26 | 15 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 27 (Month 100), A-NCS, n=19 | 21 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 27 (Month 100), A-CS, n=19 | 16 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 28 (Month 104), A-NCS, n=17 | 24 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 28 (Month 104), A-CS, n=17 | 24 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 29 (Month 108), A-NCS, n=13 | 31 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Visit 29 (Month 108), A-CS, n=13 | 8 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Follow up visit, A-NCS, n=263 | 22 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Neurological Examination | Follow up visit, A-CS, n=263 | 8 Percentage of participants |
Primary
Percentage of Participants With Abnormal Results of Physical Examination
A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed.
Time frame: Baseline and up to 122 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 5 (Month 12), n=234 | 18 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 8 (Month 24), n=166 | 17 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 17 (Month 60), n=88 | 19 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Follow up visit, n=260 | 27 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 11 (Month 36), n=121 | 21 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 14 (Month 48), n=104 | 19 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 20 (Month 72), n=58 | 24 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 23 (Month 84), n=32 | 34 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 26 (Month 96), n=26 | 35 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Results of Physical Examination | Visit 29 (Month 108), n=13 | 38 Percentage of participants |
Secondary
Number of Participants Who Were Seizure Free for Any 12 Continuous Months
Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented.
Time frame: Up to 12 continuous months within the 121 months period
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine | Number of Participants Who Were Seizure Free for Any 12 Continuous Months | 22 Participants |
Secondary
Number of Participants Who Were Seizure Free for Any 6 Continuous Months
Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented.
Time frame: Up to 6 continuous months within the 121 months period
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine | Number of Participants Who Were Seizure Free for Any 6 Continuous Months | 36 Participants |
Secondary
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. Only those participants available at the specified time points were analyzed.
Time frame: 3 years and 10 months
Population: All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retigabine | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Retinal pigmentary abnormality | 0 Participants |
| Retigabine | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Pigmentary abnormality of macula | 1 Participants |
| Retigabine | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Pigmentary abnormality of peripheral retina | 2 Participants |
| Retigabine | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Non-retinal ocular pigmentary abnormality | 8 Participants |
Secondary
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine
An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.
Time frame: 3 years and 10 months
Population: All SFUCP Subjects Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retigabine | Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | 7 Participants |
Secondary
Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment.
28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as (\[28-day partial seizure frequency for the period of interest - Baseline 28-day partial seizure frequency\] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed.
Time frame: Baseline and up to 121 months
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retigabine | Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment. | -36.1 Percent change | Standard Deviation 95.77 |
Secondary
Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment
A Responder was defined as a participant with \>=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented.
Time frame: Baseline and up to 121 months
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine | Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment | 52 Percentage of participants |
Secondary
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa
Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented.
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of non sun-exposed tissue | 37 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Any abnormal dermatologic discoloration | 50 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of skin | 37 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of lips | 26 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of nails | 41 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of mucosa | 30 Percentage of participants |
| Retigabine | Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of sun-exposed tissue | 48 Percentage of participants |
Secondary
Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination
VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination | CSD in VA from initial examination, n=38 | 13 Percentage of participants |
| Retigabine | Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination | CSD which can be explained (Form 2), n=34 | 12 Percentage of participants |
| Retigabine | Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination | CSD which can not be explained (Form 2), n=34 | 0 Percentage of participants |
Secondary
Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination
The parameter assessed was decrease in confrontation visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retigabine | Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination | 13 Percentage of participants |
Secondary
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn)
Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented.
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | ABP of the lens | 0 Percentage of participants |
| Retigabine | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | Non-ret. Pig. Abn | 28 Percentage of participants |
| Retigabine | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | ABP of sclera and/or conjunctiva | 13 Percentage of participants |
| Retigabine | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | ABP of the cornea | 4 Percentage of participants |
| Retigabine | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) | ABP of the iris | 17 Percentage of participants |
Secondary
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA)
RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented..
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retigabine | Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | PA of the PR | 22 Percentage of participants |
| Retigabine | Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | RPA | 31 Percentage of participants |
| Retigabine | Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | PA in the macula | 22 Percentage of participants |
| Retigabine | Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | PA in both the macula and PR | 13 Percentage of participants |
| Retigabine | Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) | PA: location unspecified | 2 Percentage of participants |
Secondary
Percentage of Seizure Free Days
A seizure free day is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed.
Time frame: Up to 121 months
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retigabine | Percentage of Seizure Free Days | 76.8 Percentage of days | Standard Deviation 26.11 |
Secondary
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.
Time frame: 3 years and 10 months
Population: All SFUCP Subjects Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Retigabine | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Pigmentary Abnormality of Macula, n=1 | 233.0 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Pigmentary Abnormality of Peripheral Retina, n=2 | 307.0 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Non-Retinal Ocular Pigmentary Abnormality, n=8 | 312.0 Days |
| Unknown | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Retinal Pigmentary Abnormality, n=0 | — Days |
Secondary
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.
Time frame: 3 years and 10 months
Population: All SFUCP Subjects Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Retigabine | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | All, n=7 | 380.0 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Skin, n=6 | 382.5 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Lips, n=5 | 379.0 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Nails,n=7 | 379.0 Days |
| Retigabine | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Mucosa, n=8 | 201.0 Days |