Epilepsy
Conditions
Keywords
Epilepsy, Partial Seizures, Potassium Channels, Anticonvulsant, Complex Partial Seizures, Epilepsies, Partial, RTG115098
Brief summary
The purpose of this 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 VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.
Detailed description
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 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 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. 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
DRUGEzogabine: USAN Retigabine (International Nonproprietary Name)
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 patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
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-E22-301 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-E22-301 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 |
|---|---|---|
| Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | 2 years 9 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. |
| Number of Participants With Pigmentation of Retinal Ocular Tissue | Assessed up to a maximum of 9 years | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed. |
| Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | Assessed up to a maximum of 9 years | A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed. |
| Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination | Assessed up to a maximum of 9 years | Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment. |
| Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | 2 years and 9 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 and non-retinal ocular pigmentary abnormality. |
| Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | 2 years 9 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 | 2 years 9 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. |
| Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) | Assessed up to a maximum of 9 years | An AE is 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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. |
| Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug | Assessed up to a maximum of 9 years | Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported. |
| Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Assessed up to a maximum of 9 years | The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as events. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title). |
| Change From Baseline in Blood Pressure | Baseline and Up to Month 108 | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available. |
| Change From Baseline in Heart Rate | Baseline and Up to Month 108 | Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Body Temperature | Baseline and Up to Month 108 | Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available |
| Change From Baseline in Weight | Baseline and Up to Month 108 | Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | Baseline and Up to Month 108 | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | Baseline and Up to Month 108 | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | Baseline and Up to Month 108 | A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Baseline and Up to Month 108 | Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Hematology Parameter-Red Blood Cell Count | Baseline and Up to Month 108 | Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. |
| Change From Baseline in Haematocrit | Baseline and Up to Month 108 | Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Change From Baseline in Haemoglobin | Baseline and Up to Month 108 | Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.. |
| Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | Baseline and Up to Month 108 | Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Baseline and Up to Month 108 | Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Baseline and Up to Month 108 | Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Chemistry Parameter-Total Protein | Baseline and Up to Month 108 | Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants 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 Month 108 | Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Urine Power of Hydrogen (pH) | Baseline and Up to Month 108 | Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available. |
| Change From Baseline in Post-void Residual Bladder Ultrasound Volume | Baseline and Up to Month 108 | Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) |
| Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Assessed up to a maximum of 9 years | An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa |
| Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | Baseline and Up to Month 108 | An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and \>19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) |
| Number of Participants With Abnormal Results in Physical Examination | Up to Month 108 | A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category |
| Number of Participants With Abnormal Results of Neurological Examination | Up to Month 108 | Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) |
| Number of Participants With Pigmentation of Non-retinal Ocular Tissue | Assessed up to a maximum of 9 years | The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders | Assessed up to a maximum of 9 years | A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed. |
| Number of Participants Who Were Seizure Free for Any 6 Continuous Months | Assessed up to a maximum of 9 years | Number of seizure free days 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. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as \>= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. |
| Number of Participants Who Were Seizure Free for Any 12 Continuous Months | Assessed up to a maximum of 9 years | Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as \>= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed. |
| Percentage of Seizure-free Days | Assessed up to a maximum of 9 years | Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days |
| Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Assessed up to a maximum of 9 years | The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles) |
| Percentage Change From Baseline in the 28-day Partial Seizure | Assessed up to a maximum of 9 years | Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed. |
Countries
Argentina, Brazil, Canada, Mexico, United States
Participant flow
Recruitment details
Eligible Participants (Par) who completed the Maintenance and Transition Phases of the parent study were enrolled in this open-label extension study. Par received 600-1200 mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.
Pre-assignment details
All participants who completed Study VRX-RET-E22-301(parent study) and did not have an ongoing serious adverse event (SAE) were eligible to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo in Parent Study Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm. | 102 |
| Retigabine in Parent Study Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm. | 79 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Primary Reporting Phase | Adverse Event | 28 | 22 | 0 |
| Primary Reporting Phase | Change in Par medical condition | 2 | 0 | 0 |
| Primary Reporting Phase | Failed to return | 1 | 3 | 0 |
| Primary Reporting Phase | Going for temporal lobectomy | 1 | 0 | 0 |
| Primary Reporting Phase | Lack of Efficacy | 24 | 19 | 0 |
| Primary Reporting Phase | Missed study drug >5 days | 1 | 0 | 0 |
| Primary Reporting Phase | Missed study drug for 2 months | 1 | 0 | 0 |
| Primary Reporting Phase | Par. switched to commercial product | 0 | 1 | 0 |
| Primary Reporting Phase | Participant request unrelated to study | 1 | 2 | 0 |
| Primary Reporting Phase | Physician Decision | 5 | 3 | 0 |
| Primary Reporting Phase | Pregnancy | 2 | 2 | 0 |
| Primary Reporting Phase | Protocol Violation | 8 | 5 | 0 |
| Primary Reporting Phase | Request of Ethics Committee | 0 | 1 | 0 |
| Primary Reporting Phase | Request of the sponsor | 2 | 2 | 0 |
| Primary Reporting Phase | Site closure | 3 | 0 | 0 |
| Primary Reporting Phase | Transaminase >5 upper limit of normal | 2 | 1 | 0 |
| Primary Reporting Phase | Withdrawal by Subject | 10 | 7 | 0 |
| Safety Follow-up Continuation Phase | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Retigabine in Parent Study | Total | Placebo in Parent Study |
|---|---|---|---|
| Age, Continuous | 37.1 Years STANDARD_DEVIATION 12.2 | 37.6 Years STANDARD_DEVIATION 11.92 | 38.0 Years STANDARD_DEVIATION 11.74 |
| Clinical Global Impression (CGI) at Baseline Among the Most Extremely Severe | 0 Participants | 0 Participants | 0 Participants |
| Clinical Global Impression (CGI) at Baseline Marked Severity | 26 Participants | 62 Participants | 36 Participants |
| Clinical Global Impression (CGI) at Baseline Mild Severity | 8 Participants | 17 Participants | 9 Participants |
| Clinical Global Impression (CGI) at Baseline Moderate Severity | 40 Participants | 89 Participants | 49 Participants |
| Clinical Global Impression (CGI) at Baseline No Seizures | 0 Participants | 0 Participants | 0 Participants |
| Clinical Global Impression (CGI) at Baseline Not Assessed | 0 Participants | 0 Participants | 0 Participants |
| Clinical Global Impression (CGI) at Baseline Very Mild Severity | 0 Participants | 2 Participants | 2 Participants |
| Clinical Global Impression (CGI) at Baseline Very Severe | 5 Participants | 11 Participants | 6 Participants |
| Mean Duration of Generalized Seizure | 25.8 Years STANDARD_DEVIATION 13.25 | 21.5 Years STANDARD_DEVIATION 12.94 | 18.6 Years STANDARD_DEVIATION 12.45 |
| Mean Duration of Partial seizures | 23.7 Years STANDARD_DEVIATION 12.88 | 23.9 Years STANDARD_DEVIATION 12.95 | 24.1 Years STANDARD_DEVIATION 13.06 |
| Number of background AEDs AED=1 | 18 Participants | 30 Participants | 12 Participants |
| Number of background AEDs AED=2 | 41 Participants | 88 Participants | 47 Participants |
| Number of background AEDs AED=3 | 20 Participants | 63 Participants | 43 Participants |
| Number of Participants with Vagal nerve stimulator (VNS) use No | 74 Participants | 163 Participants | 89 Participants |
| Number of Participants with Vagal nerve stimulator (VNS) use Yes | 5 Participants | 18 Participants | 13 Participants |
| Race/Ethnicity, Customized African-American (black) | 7 Participants | 14 Participants | 7 Participants |
| Race/Ethnicity, Customized Caucasian | 40 Participants | 94 Participants | 54 Participants |
| Race/Ethnicity, Customized Hispanic | 26 Participants | 56 Participants | 30 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 17 Participants | 11 Participants |
| Sex: Female, Male Female | 39 Participants | 94 Participants | 55 Participants |
| Sex: Female, Male Male | 40 Participants | 87 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 181 |
| other Total, other adverse events | 169 / 181 |
| serious Total, serious adverse events | 48 / 181 |
Outcome results
Primary
Change From Baseline in Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 1, n=173 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 9.74 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 3, n=159 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 9.73 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 6, n=143 | -2.9 Millimeter of mercury (mmHg) | Standard Deviation 10.61 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 28, n=88 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 12.75 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 44, n=76 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 11.75 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 48, n=82 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 11.76 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 60, n=70 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 11.67 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 68, n=45 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 11.24 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 72, n=57 | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 11.02 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 9, n=125 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 10.17 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 12, n=170 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.18 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 28, n=87 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 12.83 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 48, n=81 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 11.74 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 64, n=49 | -2.1 Millimeter of mercury (mmHg) | Standard Deviation 11.94 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 68, n=45 | -2.9 Millimeter of mercury (mmHg) | Standard Deviation 11.91 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 76, n=30 | -2.4 Millimeter of mercury (mmHg) | Standard Deviation 13.08 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 80, n=23 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 10.86 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 84, n=34 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 12.17 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 88, n=17 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 8.99 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 96, n=19 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 8.81 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 100, n=7 | -4.9 Millimeter of mercury (mmHg) | Standard Deviation 4.41 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 104, n=1 | -20.0 Millimeter of mercury (mmHg) | — |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 108, n=10 | -4.5 Millimeter of mercury (mmHg) | Standard Deviation 5.46 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 1, n=173 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 14.7 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 3, n=159 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 12.96 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 6, n=143 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 14.78 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 9, n=125 | -0.4 Millimeter of mercury (mmHg) | Standard Deviation 14.14 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 12, n=173 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 15.7 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 16, n=104 | -2.2 Millimeter of mercury (mmHg) | Standard Deviation 15.08 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 20, n=100 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 15.62 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 24, n=112 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 16.11 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 32, n=85 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 16.57 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 40, n=78 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 15.08 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 44, n=76 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 16.62 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 48, n=82 | 2.6 Millimeter of mercury (mmHg) | Standard Deviation 15.99 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 52, n=68 | 3.3 Millimeter of mercury (mmHg) | Standard Deviation 15.32 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 56, n=63 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 15.3 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 60, n=70 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 13.57 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 64, n=50 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 18.76 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 68, n=45 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 18.29 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 72, n=57 | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 17.21 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 76, n=31 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 17.42 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 80, n=24 | -2.6 Millimeter of mercury (mmHg) | Standard Deviation 12.8 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 84, n=36 | -3.0 Millimeter of mercury (mmHg) | Standard Deviation 18.16 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 88, n=17 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 12.07 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 92, n=16 | -0.9 Millimeter of mercury (mmHg) | Standard Deviation 17.07 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 100, n=7 | -3.6 Millimeter of mercury (mmHg) | Standard Deviation 9.95 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 108, n=10 | -4.4 Millimeter of mercury (mmHg) | Standard Deviation 16.6 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 1, n=173 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 14.1 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 3, n=159 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 15.38 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 6, n=143 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 14.35 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 9, n=125 | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 14.84 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 12, n=170 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 15.25 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 20, n=100 | 2.1 Millimeter of mercury (mmHg) | Standard Deviation 16.05 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 24, n=110 | 3.8 Millimeter of mercury (mmHg) | Standard Deviation 17.42 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 28, n=87 | 1.6 Millimeter of mercury (mmHg) | Standard Deviation 15.53 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 32, n=84 | 3.1 Millimeter of mercury (mmHg) | Standard Deviation 17.06 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 36, n=91 | 1.7 Millimeter of mercury (mmHg) | Standard Deviation 15.2 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 40, n=77 | 1.7 Millimeter of mercury (mmHg) | Standard Deviation 16.79 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 44, n=75 | 2.7 Millimeter of mercury (mmHg) | Standard Deviation 15.8 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 48, n=81 | 3.3 Millimeter of mercury (mmHg) | Standard Deviation 14.51 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 52, n=67 | 3.9 Millimeter of mercury (mmHg) | Standard Deviation 18.37 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 56, n=62 | 2.7 Millimeter of mercury (mmHg) | Standard Deviation 13.99 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 60, n=69 | 2.1 Millimeter of mercury (mmHg) | Standard Deviation 13.41 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 64, n=49 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 17.27 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 68, n=45 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 15.98 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 72, n=56 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 17.23 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 76, n=30 | -4.5 Millimeter of mercury (mmHg) | Standard Deviation 17.63 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 80, n=23 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 13.7 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 84, n=34 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 13.46 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 88, n=17 | 2.1 Millimeter of mercury (mmHg) | Standard Deviation 11.89 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 92, n=16 | -4.9 Millimeter of mercury (mmHg) | Standard Deviation 14.38 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 96, n=19 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 12.24 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 100, n=7 | -4.6 Millimeter of mercury (mmHg) | Standard Deviation 11.16 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 104, n=1 | -22.0 Millimeter of mercury (mmHg) | — |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 28, n=88 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 16.06 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 36, n=92 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 15.78 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 96, n=19 | -0.9 Millimeter of mercury (mmHg) | Standard Deviation 12.33 |
| Overall Study | Change From Baseline in Blood Pressure | Su SBP Mon 104, n=1 | -20.0 Millimeter of mercury (mmHg) | — |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 16, n=104 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 14.69 |
| Overall Study | Change From Baseline in Blood Pressure | St SBP Mon 108, n=10 | -5.5 Millimeter of mercury (mmHg) | Standard Deviation 7.14 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 9, n=125 | -2.6 Millimeter of mercury (mmHg) | Standard Deviation 10.72 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 12, n=173 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 11.08 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 16, n=104 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 11.69 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 20, n=100 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 13.12 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 24, n=112 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 11.24 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 32, n=85 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 11.18 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 36, n=92 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 10.81 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 40, n=78 | -2.5 Millimeter of mercury (mmHg) | Standard Deviation 11.62 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 52, n=68 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 9.74 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 56, n=63 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 11.37 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 64, n=50 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 11.34 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 76, n=31 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 9.01 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 80, n=24 | -1 Millimeter of mercury (mmHg) | Standard Deviation 7.13 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 84, n=36 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 11.04 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 88, n=17 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 6.94 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 92, n=16 | -2.8 Millimeter of mercury (mmHg) | Standard Deviation 8.49 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 96, n=19 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 8.3 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 100, n=7 | -6.3 Millimeter of mercury (mmHg) | Standard Deviation 3.25 |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 104, n=1 | -20.0 Millimeter of mercury (mmHg) | — |
| Overall Study | Change From Baseline in Blood Pressure | Su DBP Mon 108, n=10 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 7.27 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 1, n=173 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 9.97 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 3, n=159 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.68 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 6, n=143 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 11.47 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 16, n=104 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 11.14 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 20, n=100 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 12.02 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 24, n=110 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 11.78 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 32, n=84 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 11.95 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 36, n=91 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 10.78 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 40, n=77 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 11.09 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 44, n=75 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 11.67 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 52, n=67 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.49 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 56, n=62 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.2 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 60, n=69 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 14.12 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 72, n=56 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 11.13 |
| Overall Study | Change From Baseline in Blood Pressure | St DBP Mon 92, n=16 | -3.1 Millimeter of mercury (mmHg) | Standard Deviation 9.84 |
Primary
Change From Baseline in Body Temperature
Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 1, n=174 | -0.04 Degree Celsius | Standard Deviation 0.437 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 3, n=158 | -0.08 Degree Celsius | Standard Deviation 0.46 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 6, n=142 | -0.05 Degree Celsius | Standard Deviation 0.455 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 9, n=124 | -0.06 Degree Celsius | Standard Deviation 0.479 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 12, n=172 | -0.07 Degree Celsius | Standard Deviation 0.489 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 16, n=102 | -0.01 Degree Celsius | Standard Deviation 0.477 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 20, n=98 | -0.00 Degree Celsius | Standard Deviation 0.495 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 24, n=110 | -0.07 Degree Celsius | Standard Deviation 0.532 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 28, n=86 | -0.08 Degree Celsius | Standard Deviation 0.457 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 32, n=85 | -0.09 Degree Celsius | Standard Deviation 0.456 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 36, n=92 | -0.13 Degree Celsius | Standard Deviation 0.543 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 40, n=77 | -0.12 Degree Celsius | Standard Deviation 0.492 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 44, n=76 | -0.07 Degree Celsius | Standard Deviation 0.523 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 48, n=82 | -0.06 Degree Celsius | Standard Deviation 0.525 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 52, n=68 | -0.13 Degree Celsius | Standard Deviation 0.439 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 56, n=63 | -0.09 Degree Celsius | Standard Deviation 0.566 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 60, n=70 | -0.02 Degree Celsius | Standard Deviation 0.436 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 64, n=48 | -0.12 Degree Celsius | Standard Deviation 0.451 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 68, n=45 | -0.01 Degree Celsius | Standard Deviation 0.497 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 72, n=57 | -0.06 Degree Celsius | Standard Deviation 0.433 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 76, n=31 | -0.04 Degree Celsius | Standard Deviation 0.506 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 80, n=24 | -0.08 Degree Celsius | Standard Deviation 0.472 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 84, n=36 | -0.19 Degree Celsius | Standard Deviation 0.481 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 88, n=17 | -0.20 Degree Celsius | Standard Deviation 0.496 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 92, n=16 | -0.14 Degree Celsius | Standard Deviation 0.542 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 96, n=19 | -0.26 Degree Celsius | Standard Deviation 0.512 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 100, n=7 | -0.14 Degree Celsius | Standard Deviation 0.69 |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 104, n=1 | 1.00 Degree Celsius | — |
| Overall Study | Change From Baseline in Body Temperature | Temperature, Mon 108, n=10 | -0.15 Degree Celsius | Standard Deviation 0.645 |
Primary
Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)
Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 9, n=108 | -7.7 International units per litre (IU/L) | Standard Deviation 23.88 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 12, n=149 | -6.1 International units per litre (IU/L) | Standard Deviation 21.91 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 16, n=87 | -9.1 International units per litre (IU/L) | Standard Deviation 22.3 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 20, n=85 | -5.0 International units per litre (IU/L) | Standard Deviation 23.46 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 24, n=95 | -7.1 International units per litre (IU/L) | Standard Deviation 22.88 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 28, n=75 | -6.3 International units per litre (IU/L) | Standard Deviation 23.89 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 32, n=73 | -7.8 International units per litre (IU/L) | Standard Deviation 23.52 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 36, n=77 | -4.8 International units per litre (IU/L) | Standard Deviation 20.58 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 40, n=67 | -6.3 International units per litre (IU/L) | Standard Deviation 23.26 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 44, n=63 | -8.2 International units per litre (IU/L) | Standard Deviation 21.05 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 48, n=70 | -7.5 International units per litre (IU/L) | Standard Deviation 23.66 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 52, n=59 | -9.7 International units per litre (IU/L) | Standard Deviation 22.18 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 56, n=54 | -9.9 International units per litre (IU/L) | Standard Deviation 23.41 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 60, n=61 | -7.7 International units per litre (IU/L) | Standard Deviation 21.83 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 64, n=44 | -2.8 International units per litre (IU/L) | Standard Deviation 29.2 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 68, n=36 | -8.7 International units per litre (IU/L) | Standard Deviation 24.79 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 72, n=46 | -4.5 International units per litre (IU/L) | Standard Deviation 24.32 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 76, n=26 | -5.0 International units per litre (IU/L) | Standard Deviation 23.34 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 80, n=21 | -8.9 International units per litre (IU/L) | Standard Deviation 28.32 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 84, n=30 | -1.7 International units per litre (IU/L) | Standard Deviation 24.36 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 88, n=15 | -9.9 International units per litre (IU/L) | Standard Deviation 19.57 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 92, n=15 | -6.5 International units per litre (IU/L) | Standard Deviation 24.01 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 96, n=18 | -3.9 International units per litre (IU/L) | Standard Deviation 17.32 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 100, n=6 | -12.3 International units per litre (IU/L) | Standard Deviation 26.47 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 104, n=1 | 11.0 International units per litre (IU/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 1, n=169 | 3.1 International units per litre (IU/L) | Standard Deviation 16.74 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 3, n=152 | 4.0 International units per litre (IU/L) | Standard Deviation 16.61 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 9, n=122 | 5.2 International units per litre (IU/L) | Standard Deviation 43.44 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 12, n=169 | 4.5 International units per litre (IU/L) | Standard Deviation 26.42 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 16, n=100 | -0.3 International units per litre (IU/L) | Standard Deviation 11.05 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 20, n=96 | 1.1 International units per litre (IU/L) | Standard Deviation 10.89 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 24, n=108 | 3.0 International units per litre (IU/L) | Standard Deviation 11.61 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 28, n=87 | 2.2 International units per litre (IU/L) | Standard Deviation 12.65 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 32, n=85 | 2.0 International units per litre (IU/L) | Standard Deviation 14.39 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 36, n=89 | 1.7 International units per litre (IU/L) | Standard Deviation 10.36 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 40, n=77 | 2.5 International units per litre (IU/L) | Standard Deviation 12.6 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 44, n=73 | 4.1 International units per litre (IU/L) | Standard Deviation 13.29 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 48, n=78 | 3.0 International units per litre (IU/L) | Standard Deviation 12.25 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 52, n=67 | 2.3 International units per litre (IU/L) | Standard Deviation 12.15 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 56, n=62 | 1.4 International units per litre (IU/L) | Standard Deviation 9.94 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 60, n=69 | 1.0 International units per litre (IU/L) | Standard Deviation 11.73 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 64, n=48 | 0.2 International units per litre (IU/L) | Standard Deviation 10.24 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 68, n=41 | -0.5 International units per litre (IU/L) | Standard Deviation 9.11 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 72, n=51 | 0.4 International units per litre (IU/L) | Standard Deviation 10.15 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 76, n=30 | 0.6 International units per litre (IU/L) | Standard Deviation 6.14 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 80, n=22 | 0.4 International units per litre (IU/L) | Standard Deviation 12.38 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 84, n=33 | 1.1 International units per litre (IU/L) | Standard Deviation 12.05 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 88, n=15 | -1.3 International units per litre (IU/L) | Standard Deviation 12.29 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 92, n=15 | 2.1 International units per litre (IU/L) | Standard Deviation 8.09 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 100, n=6 | 0.8 International units per litre (IU/L) | Standard Deviation 9.41 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 104, n=1 | -6.0 International units per litre (IU/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 3, n=152 | 3.2 International units per litre (IU/L) | Standard Deviation 10.07 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 6, n=137 | 1.7 International units per litre (IU/L) | Standard Deviation 7.89 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 9, n=121 | 6.0 International units per litre (IU/L) | Standard Deviation 35.18 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 12, n=169 | 3.9 International units per litre (IU/L) | Standard Deviation 14.84 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 16, n=100 | 2.1 International units per litre (IU/L) | Standard Deviation 8.49 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 20, n=96 | 2.9 International units per litre (IU/L) | Standard Deviation 8.03 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 28, n=86 | 4.3 International units per litre (IU/L) | Standard Deviation 9.16 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 32, n=85 | 5.6 International units per litre (IU/L) | Standard Deviation 8.64 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 36, n=89 | 3.9 International units per litre (IU/L) | Standard Deviation 6.74 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 40, n=77 | 5.0 International units per litre (IU/L) | Standard Deviation 9.93 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 44, n=73 | 4.6 International units per litre (IU/L) | Standard Deviation 7.84 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 48, n=78 | 4.7 International units per litre (IU/L) | Standard Deviation 8.61 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 52, n=67 | 6.0 International units per litre (IU/L) | Standard Deviation 8.68 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 72, n=51 | 5.1 International units per litre (IU/L) | Standard Deviation 9.54 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 76, n=30 | 4.9 International units per litre (IU/L) | Standard Deviation 6.59 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 80, n=22 | 4.6 International units per litre (IU/L) | Standard Deviation 7.74 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 84, n=33 | 5.6 International units per litre (IU/L) | Standard Deviation 8.6 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 88, n=15 | 2.9 International units per litre (IU/L) | Standard Deviation 6.99 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 92, n=15 | 3.3 International units per litre (IU/L) | Standard Deviation 3.24 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 96, n=18 | 3.1 International units per litre (IU/L) | Standard Deviation 6.58 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 104, n=1 | 2.0 International units per litre (IU/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 108, n=9 | 1.8 International units per litre (IU/L) | Standard Deviation 5.49 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 1, n=151 | -5.5 International units per litre (IU/L) | Standard Deviation 19.98 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 3, n=136 | -5.7 International units per litre (IU/L) | Standard Deviation 19.47 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 6, n=122 | -7.3 International units per litre (IU/L) | Standard Deviation 19.09 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AP, Mon 108, n=9 | -14.2 International units per litre (IU/L) | Standard Deviation 21.81 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 6, n=137 | 1.2 International units per litre (IU/L) | Standard Deviation 10.45 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 96, n=18 | 2.2 International units per litre (IU/L) | Standard Deviation 13.81 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | ALT, Mon 108, n=9 | -1.3 International units per litre (IU/L) | Standard Deviation 6.86 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 1, n=169 | 2.9 International units per litre (IU/L) | Standard Deviation 10.79 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 24, n=108 | 4.1 International units per litre (IU/L) | Standard Deviation 9.72 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 56, n=62 | 4.3 International units per litre (IU/L) | Standard Deviation 7.61 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 60, n=69 | 5.4 International units per litre (IU/L) | Standard Deviation 9.34 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 64, n=48 | 3.8 International units per litre (IU/L) | Standard Deviation 8.5 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 68, n=41 | 5.3 International units per litre (IU/L) | Standard Deviation 7.13 |
| Overall Study | Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) | AST, Mon 100, n=6 | 3.7 International units per litre (IU/L) | Standard Deviation 4.23 |
Primary
Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea
Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 3, n=142 | 0.843 Millimole per liter (mmol/L) | Standard Deviation 1.2012 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 6, n=130 | 0.917 Millimole per liter (mmol/L) | Standard Deviation 1.3506 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 9, n=115 | 0.823 Millimole per liter (mmol/L) | Standard Deviation 1.4786 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 16, n=94 | 0.973 Millimole per liter (mmol/L) | Standard Deviation 1.5385 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 52, n=62 | 1.071 Millimole per liter (mmol/L) | Standard Deviation 1.4554 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 56, n=57 | 1.022 Millimole per liter (mmol/L) | Standard Deviation 1.2697 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 60, n=64 | 1.100 Millimole per liter (mmol/L) | Standard Deviation 1.4931 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 68, n=37 | 1.148 Millimole per liter (mmol/L) | Standard Deviation 1.4599 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 100, n=6 | 1.248 Millimole per liter (mmol/L) | Standard Deviation 1.5755 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 104, n=1 | 1.430 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 108, n=9 | 0.183 Millimole per liter (mmol/L) | Standard Deviation 1.2637 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 1, n=170 | -0.034 Millimole per liter (mmol/L) | Standard Deviation 0.1094 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 36, n=89 | 0.032 Millimole per liter (mmol/L) | Standard Deviation 0.1176 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 40, n=77 | 0.030 Millimole per liter (mmol/L) | Standard Deviation 0.1195 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 48, n=80 | 0.054 Millimole per liter (mmol/L) | Standard Deviation 0.1161 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 52, n=67 | 0.047 Millimole per liter (mmol/L) | Standard Deviation 0.117 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 60, n=69 | 0.061 Millimole per liter (mmol/L) | Standard Deviation 0.1184 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 68, n=41 | 0.083 Millimole per liter (mmol/L) | Standard Deviation 0.1245 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 76, n=30 | 0.097 Millimole per liter (mmol/L) | Standard Deviation 0.1341 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 80, n=22 | 0.069 Millimole per liter (mmol/L) | Standard Deviation 0.1289 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 92, n=15 | 0.116 Millimole per liter (mmol/L) | Standard Deviation 0.1013 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 96, n=18 | 0.106 Millimole per liter (mmol/L) | Standard Deviation 0.0887 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 100, n=6 | 0.148 Millimole per liter (mmol/L) | Standard Deviation 0.1217 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 3, n=151 | 0.075 Millimole per liter (mmol/L) | Standard Deviation 0.6672 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 6, n=137 | 0.069 Millimole per liter (mmol/L) | Standard Deviation 0.6811 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 12, n=169 | 0.222 Millimole per liter (mmol/L) | Standard Deviation 0.7098 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 24, n=109 | 0.260 Millimole per liter (mmol/L) | Standard Deviation 0.7731 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 32, n=85 | 0.261 Millimole per liter (mmol/L) | Standard Deviation 0.8061 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 36, n=89 | 0.212 Millimole per liter (mmol/L) | Standard Deviation 0.8312 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 44, n=73 | 0.348 Millimole per liter (mmol/L) | Standard Deviation 0.7824 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 52, n=67 | 0.299 Millimole per liter (mmol/L) | Standard Deviation 0.723 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 56, n=62 | 0.305 Millimole per liter (mmol/L) | Standard Deviation 0.7202 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 100, n=6 | 0.483 Millimole per liter (mmol/L) | Standard Deviation 0.4126 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 1, n=170 | 0.11 Millimole per liter (mmol/L) | Standard Deviation 0.929 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 3, n=149 | 0.20 Millimole per liter (mmol/L) | Standard Deviation 0.844 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 9, n=120 | 0.38 Millimole per liter (mmol/L) | Standard Deviation 2.585 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 32, n=85 | 0.16 Millimole per liter (mmol/L) | Standard Deviation 1.39 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 68, n=39 | 0.32 Millimole per liter (mmol/L) | Standard Deviation 0.7 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 76, n=30 | 0.17 Millimole per liter (mmol/L) | Standard Deviation 0.505 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 80, n=22 | 0.15 Millimole per liter (mmol/L) | Standard Deviation 0.776 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 84, n=34 | 0.23 Millimole per liter (mmol/L) | Standard Deviation 0.572 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 100, n=6 | 0.25 Millimole per liter (mmol/L) | Standard Deviation 0.176 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 20, n=94 | 0.003 Millimole per liter (mmol/L) | Standard Deviation 0.2229 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 24, n=105 | -0.021 Millimole per liter (mmol/L) | Standard Deviation 0.2186 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 28, n=86 | -0.020 Millimole per liter (mmol/L) | Standard Deviation 0.1974 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 32, n=84 | 0.019 Millimole per liter (mmol/L) | Standard Deviation 0.1767 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 44, n=73 | 0.018 Millimole per liter (mmol/L) | Standard Deviation 0.2631 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 96, n=18 | 0.026 Millimole per liter (mmol/L) | Standard Deviation 0.3294 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 100, n=6 | 0.143 Millimole per liter (mmol/L) | Standard Deviation 0.1656 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 108, n=9 | -0.068 Millimole per liter (mmol/L) | Standard Deviation 0.3755 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 24, n=106 | -0.00 Millimole per liter (mmol/L) | Standard Deviation 0.435 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 28, n=86 | -0.01 Millimole per liter (mmol/L) | Standard Deviation 0.437 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 52, n=67 | 0.20 Millimole per liter (mmol/L) | Standard Deviation 0.448 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 56, n=62 | 0.08 Millimole per liter (mmol/L) | Standard Deviation 0.374 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 60, n=69 | 0.13 Millimole per liter (mmol/L) | Standard Deviation 0.511 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 72, n=52 | 0.24 Millimole per liter (mmol/L) | Standard Deviation 0.546 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 84, n=34 | 0.24 Millimole per liter (mmol/L) | Standard Deviation 0.483 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 96, n=18 | 0.41 Millimole per liter (mmol/L) | Standard Deviation 0.407 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 104, n=1 | 1.10 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 108, n=9 | 0.51 Millimole per liter (mmol/L) | Standard Deviation 0.437 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 1, n=170 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 3.44 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 3, n=153 | 1.4 Millimole per liter (mmol/L) | Standard Deviation 2.88 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 12, n=170 | 1.1 Millimole per liter (mmol/L) | Standard Deviation 3.68 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 28, n=87 | 1.4 Millimole per liter (mmol/L) | Standard Deviation 3.06 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 32, n=85 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.46 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 36, n=89 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 3.84 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 40, n=77 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.78 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 48, n=80 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.31 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 1, n=13 | 0.712 Millimole per liter (mmol/L) | Standard Deviation 1.1012 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 6, n=7 | 0.304 Millimole per liter (mmol/L) | Standard Deviation 1.1204 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 16, n=6 | 1.070 Millimole per liter (mmol/L) | Standard Deviation 2.1793 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 20, n=5 | 0.856 Millimole per liter (mmol/L) | Standard Deviation 0.7814 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 24, n=8 | 0.668 Millimole per liter (mmol/L) | Standard Deviation 1.0143 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 28, n=5 | 1.498 Millimole per liter (mmol/L) | Standard Deviation 0.9608 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 32, n=5 | 0.784 Millimole per liter (mmol/L) | Standard Deviation 0.7722 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 36, n=4 | 1.337 Millimole per liter (mmol/L) | Standard Deviation 1.5564 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 40, n=5 | 1.140 Millimole per liter (mmol/L) | Standard Deviation 0.4659 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 44, n=5 | 0.784 Millimole per liter (mmol/L) | Standard Deviation 0.5269 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 52, n=5 | 0.356 Millimole per liter (mmol/L) | Standard Deviation 0.9411 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 56, n=5 | 1.356 Millimole per liter (mmol/L) | Standard Deviation 1.7009 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 64, n=5 | 1.496 Millimole per liter (mmol/L) | Standard Deviation 0.8128 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 68, n=4 | 1.695 Millimole per liter (mmol/L) | Standard Deviation 1.0242 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 72, n=3 | 1.070 Millimole per liter (mmol/L) | Standard Deviation 2.1725 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 80, n=3 | 2.380 Millimole per liter (mmol/L) | Standard Deviation 0.7398 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 84, n=4 | 1.695 Millimole per liter (mmol/L) | Standard Deviation 1.9006 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 1, n=169 | 0.4 Millimole per liter (mmol/L) | Standard Deviation 3.13 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 3, n=151 | 0.0 Millimole per liter (mmol/L) | Standard Deviation 3.27 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 6, n=136 | 0.4 Millimole per liter (mmol/L) | Standard Deviation 3.65 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 9, n=122 | 0.7 Millimole per liter (mmol/L) | Standard Deviation 3.48 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 12, n=169 | -0.0 Millimole per liter (mmol/L) | Standard Deviation 3.97 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 16, n=100 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.49 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 20, n=97 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 4.02 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 24, n=109 | 1.1 Millimole per liter (mmol/L) | Standard Deviation 3.28 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 28, n=87 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.67 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 32, n=85 | 1.7 Millimole per liter (mmol/L) | Standard Deviation 3.62 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 36, n=89 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.84 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 40, n=76 | 1.9 Millimole per liter (mmol/L) | Standard Deviation 3.89 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 44, n=73 | 2.7 Millimole per liter (mmol/L) | Standard Deviation 3.99 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 48, n=79 | 2.4 Millimole per liter (mmol/L) | Standard Deviation 3.43 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 52, n=66 | 2.8 Millimole per liter (mmol/L) | Standard Deviation 3.65 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 56, n=62 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 3.79 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 60, n=69 | 2.4 Millimole per liter (mmol/L) | Standard Deviation 4.33 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 64, n=49 | 1.9 Millimole per liter (mmol/L) | Standard Deviation 3.95 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 68, n=42 | 2.0 Millimole per liter (mmol/L) | Standard Deviation 3.84 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 72, n=51 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 3.59 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 76, n=30 | 2.2 Millimole per liter (mmol/L) | Standard Deviation 4.04 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 92, n=15 | 1.7 Millimole per liter (mmol/L) | Standard Deviation 2.55 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 96, n=18 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.73 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 104, n=1 | 1.0 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 108, n=9 | -0.4 Millimole per liter (mmol/L) | Standard Deviation 2.3 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 3, n=153 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 3.06 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 6, n=137 | 1.4 Millimole per liter (mmol/L) | Standard Deviation 3.32 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 9, n=123 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.59 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 12, n=169 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 3.73 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 16, n=100 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 3.24 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 20, n=97 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.56 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 24, n=110 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 4.12 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 28, n=87 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.45 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 32, n=85 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 3.7 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 36, n=89 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 4 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 40, n=77 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 4.12 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 44, n=74 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 3.81 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 48, n=80 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.61 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 52, n=67 | 1.4 Millimole per liter (mmol/L) | Standard Deviation 4.13 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 56, n=61 | 2.0 Millimole per liter (mmol/L) | Standard Deviation 3.29 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 60, n=69 | 1.0 Millimole per liter (mmol/L) | Standard Deviation 3.77 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 64, n=49 | 1.7 Millimole per liter (mmol/L) | Standard Deviation 3.44 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 68, n=42 | 1.2 Millimole per liter (mmol/L) | Standard Deviation 3.62 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 72, n=52 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.7 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 76, n=30 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 4.11 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 80, n=22 | 2.0 Millimole per liter (mmol/L) | Standard Deviation 3.54 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 84, n=34 | 0.9 Millimole per liter (mmol/L) | Standard Deviation 3.53 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 92, n=15 | 0.9 Millimole per liter (mmol/L) | Standard Deviation 3.11 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 96, n=18 | 0.7 Millimole per liter (mmol/L) | Standard Deviation 3.66 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 104, n=1 | 1.0 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 108, n=9 | 0.8 Millimole per liter (mmol/L) | Standard Deviation 3.56 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 12, n=156 | 0.717 Millimole per liter (mmol/L) | Standard Deviation 1.3707 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 20, n=92 | 1.060 Millimole per liter (mmol/L) | Standard Deviation 1.3001 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 24, n=102 | 0.809 Millimole per liter (mmol/L) | Standard Deviation 1.3654 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 28, n=82 | 0.876 Millimole per liter (mmol/L) | Standard Deviation 1.642 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 32, n=80 | 0.942 Millimole per liter (mmol/L) | Standard Deviation 1.5201 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 36, n=85 | 0.958 Millimole per liter (mmol/L) | Standard Deviation 1.4267 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 40, n=72 | 1.135 Millimole per liter (mmol/L) | Standard Deviation 1.5626 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 44, n=69 | 0.844 Millimole per liter (mmol/L) | Standard Deviation 1.5006 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 48, n=75 | 0.952 Millimole per liter (mmol/L) | Standard Deviation 1.5679 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 64, n=44 | 0.991 Millimole per liter (mmol/L) | Standard Deviation 1.5938 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 72, n=48 | 1.087 Millimole per liter (mmol/L) | Standard Deviation 1.6218 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 76, n=27 | 1.257 Millimole per liter (mmol/L) | Standard Deviation 1.4492 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 80, n=19 | 0.939 Millimole per liter (mmol/L) | Standard Deviation 1.6115 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 84, n=30 | 0.929 Millimole per liter (mmol/L) | Standard Deviation 1.681 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 88, n=15 | 0.881 Millimole per liter (mmol/L) | Standard Deviation 1.458 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 92, n=15 | 1.332 Millimole per liter (mmol/L) | Standard Deviation 1.9374 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | BUN, Mon 96, n=18 | 0.916 Millimole per liter (mmol/L) | Standard Deviation 1.88 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 3, n=152 | -0.013 Millimole per liter (mmol/L) | Standard Deviation 0.1107 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 6, n=137 | 0.012 Millimole per liter (mmol/L) | Standard Deviation 0.1035 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 9, n=123 | 0.020 Millimole per liter (mmol/L) | Standard Deviation 0.1006 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 12, n=169 | 0.024 Millimole per liter (mmol/L) | Standard Deviation 0.1167 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 16, n=100 | 0.042 Millimole per liter (mmol/L) | Standard Deviation 0.1143 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 20, n=97 | 0.052 Millimole per liter (mmol/L) | Standard Deviation 0.118 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 24, n=109 | 0.049 Millimole per liter (mmol/L) | Standard Deviation 0.1095 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 28, n=87 | 0.034 Millimole per liter (mmol/L) | Standard Deviation 0.1135 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 32, n=85 | 0.032 Millimole per liter (mmol/L) | Standard Deviation 0.1216 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 44, n=73 | 0.040 Millimole per liter (mmol/L) | Standard Deviation 0.1093 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 56, n=62 | 0.055 Millimole per liter (mmol/L) | Standard Deviation 0.0951 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 64, n=49 | 0.056 Millimole per liter (mmol/L) | Standard Deviation 0.1338 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 72, n=51 | 0.053 Millimole per liter (mmol/L) | Standard Deviation 0.1223 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 84, n=34 | 0.106 Millimole per liter (mmol/L) | Standard Deviation 0.1023 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 88, n=15 | 0.071 Millimole per liter (mmol/L) | Standard Deviation 0.1078 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 104, n=1 | 0.170 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ca, Mon 108, n=9 | 0.139 Millimole per liter (mmol/L) | Standard Deviation 0.1122 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 9, n=122 | 0.177 Millimole per liter (mmol/L) | Standard Deviation 0.723 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 16, n=100 | 0.310 Millimole per liter (mmol/L) | Standard Deviation 0.7312 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 20, n=97 | 0.304 Millimole per liter (mmol/L) | Standard Deviation 0.7883 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 28, n=87 | 0.261 Millimole per liter (mmol/L) | Standard Deviation 0.7771 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 40, n=77 | 0.200 Millimole per liter (mmol/L) | Standard Deviation 0.7782 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 48, n=79 | 0.170 Millimole per liter (mmol/L) | Standard Deviation 0.8571 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 60, n=69 | 0.360 Millimole per liter (mmol/L) | Standard Deviation 0.7318 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 64, n=49 | 0.256 Millimole per liter (mmol/L) | Standard Deviation 0.8771 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 68, n=41 | 0.352 Millimole per liter (mmol/L) | Standard Deviation 0.8486 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 72, n=51 | 0.216 Millimole per liter (mmol/L) | Standard Deviation 0.8548 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 76, n=30 | 0.555 Millimole per liter (mmol/L) | Standard Deviation 0.7532 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 80, n=22 | 0.442 Millimole per liter (mmol/L) | Standard Deviation 0.7078 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 84, n=34 | 0.459 Millimole per liter (mmol/L) | Standard Deviation 0.9991 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 88, n=15 | 0.408 Millimole per liter (mmol/L) | Standard Deviation 0.7559 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 92, n=15 | 0.526 Millimole per liter (mmol/L) | Standard Deviation 0.7639 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 96, n=18 | 0.352 Millimole per liter (mmol/L) | Standard Deviation 0.628 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 104, n=1 | 0.160 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cho., Mon 108, n=9 | 0.278 Millimole per liter (mmol/L) | Standard Deviation 0.3881 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 6, n=133 | 0.18 Millimole per liter (mmol/L) | Standard Deviation 1.057 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 12, n=166 | 0.20 Millimole per liter (mmol/L) | Standard Deviation 0.978 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 16, n=100 | 0.18 Millimole per liter (mmol/L) | Standard Deviation 1.167 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 20, n=94 | 0.26 Millimole per liter (mmol/L) | Standard Deviation 0.971 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 24, n=106 | 0.13 Millimole per liter (mmol/L) | Standard Deviation 0.935 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 28, n=86 | 0.22 Millimole per liter (mmol/L) | Standard Deviation 0.968 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 36, n=89 | 0.19 Millimole per liter (mmol/L) | Standard Deviation 1.176 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 40, n=75 | 0.20 Millimole per liter (mmol/L) | Standard Deviation 1.074 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 44, n=72 | 0.02 Millimole per liter (mmol/L) | Standard Deviation 1.019 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 48, n=77 | 0.27 Millimole per liter (mmol/L) | Standard Deviation 1.628 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 52, n=67 | 0.05 Millimole per liter (mmol/L) | Standard Deviation 0.877 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 56, n=61 | 0.14 Millimole per liter (mmol/L) | Standard Deviation 0.893 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 60, n=69 | 0.19 Millimole per liter (mmol/L) | Standard Deviation 1.029 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 64, n=49 | 0.21 Millimole per liter (mmol/L) | Standard Deviation 0.883 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 72, n=51 | 0.24 Millimole per liter (mmol/L) | Standard Deviation 1.037 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 88, n=15 | -0.09 Millimole per liter (mmol/L) | Standard Deviation 0.593 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 92, n=15 | 0.14 Millimole per liter (mmol/L) | Standard Deviation 0.546 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 96, n=18 | 0.22 Millimole per liter (mmol/L) | Standard Deviation 0.493 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 104, n=1 | -0.50 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | NFG, Mon 108, n=9 | 0.21 Millimole per liter (mmol/L) | Standard Deviation 0.372 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 1, n=169 | 0.014 Millimole per liter (mmol/L) | Standard Deviation 0.2037 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 3, n=148 | 0.001 Millimole per liter (mmol/L) | Standard Deviation 0.2029 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 6, n=132 | 0.020 Millimole per liter (mmol/L) | Standard Deviation 0.2148 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 9, n=119 | 0.021 Millimole per liter (mmol/L) | Standard Deviation 0.1974 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 12, n=167 | 0.007 Millimole per liter (mmol/L) | Standard Deviation 0.2401 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 16, n=100 | -0.010 Millimole per liter (mmol/L) | Standard Deviation 0.2289 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 36, n=88 | 0.004 Millimole per liter (mmol/L) | Standard Deviation 0.2896 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 40, n=75 | -0.005 Millimole per liter (mmol/L) | Standard Deviation 0.2408 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 48, n=78 | 0.019 Millimole per liter (mmol/L) | Standard Deviation 0.2165 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 52, n=67 | 0.018 Millimole per liter (mmol/L) | Standard Deviation 0.216 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 56, n=62 | 0.010 Millimole per liter (mmol/L) | Standard Deviation 0.233 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 60, n=69 | 0.071 Millimole per liter (mmol/L) | Standard Deviation 0.2389 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 64, n=49 | 0.027 Millimole per liter (mmol/L) | Standard Deviation 0.2722 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 68, n=39 | 0.007 Millimole per liter (mmol/L) | Standard Deviation 0.2453 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 72, n=51 | 0.029 Millimole per liter (mmol/L) | Standard Deviation 0.2761 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 76, n=30 | 0.038 Millimole per liter (mmol/L) | Standard Deviation 0.2506 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 80, n=22 | 0.107 Millimole per liter (mmol/L) | Standard Deviation 0.2761 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 84, n=34 | 0.046 Millimole per liter (mmol/L) | Standard Deviation 0.2518 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 88, n=15 | -0.004 Millimole per liter (mmol/L) | Standard Deviation 0.297 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 92, n=15 | 0.058 Millimole per liter (mmol/L) | Standard Deviation 0.3334 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | P, Mon 104, n=1 | -0.090 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 1, n=169 | 0.02 Millimole per liter (mmol/L) | Standard Deviation 0.416 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 3, n=149 | 0.04 Millimole per liter (mmol/L) | Standard Deviation 0.433 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 6, n=132 | 0.03 Millimole per liter (mmol/L) | Standard Deviation 0.362 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 9, n=119 | 0.08 Millimole per liter (mmol/L) | Standard Deviation 0.432 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 12, n=167 | -0.03 Millimole per liter (mmol/L) | Standard Deviation 0.442 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 16, n=100 | 0.02 Millimole per liter (mmol/L) | Standard Deviation 0.428 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 20, n=93 | 0.10 Millimole per liter (mmol/L) | Standard Deviation 0.442 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 32, n=84 | 0.01 Millimole per liter (mmol/L) | Standard Deviation 0.408 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 36, n=88 | 0.04 Millimole per liter (mmol/L) | Standard Deviation 0.482 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 40, n=74 | 0.00 Millimole per liter (mmol/L) | Standard Deviation 0.432 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 44, n=74 | 0.16 Millimole per liter (mmol/L) | Standard Deviation 0.538 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 48, n=79 | 0.12 Millimole per liter (mmol/L) | Standard Deviation 0.4 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 64, n=49 | 0.19 Millimole per liter (mmol/L) | Standard Deviation 0.407 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 68, n=40 | 0.28 Millimole per liter (mmol/L) | Standard Deviation 0.394 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 76, n=30 | 0.25 Millimole per liter (mmol/L) | Standard Deviation 0.549 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 80, n=22 | 0.35 Millimole per liter (mmol/L) | Standard Deviation 0.448 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 88, n=15 | 0.38 Millimole per liter (mmol/L) | Standard Deviation 0.43 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 92, n=15 | 0.55 Millimole per liter (mmol/L) | Standard Deviation 0.503 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Ka, Mon 100, n=6 | 0.32 Millimole per liter (mmol/L) | Standard Deviation 0.402 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 6, n=137 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 3.16 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 9, n=123 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 3.22 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 16, n=100 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 3.26 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 20, n=97 | 1.1 Millimole per liter (mmol/L) | Standard Deviation 3.33 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 24, n=110 | 0.8 Millimole per liter (mmol/L) | Standard Deviation 3.57 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 44, n=74 | 1.4 Millimole per liter (mmol/L) | Standard Deviation 3.78 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 52, n=67 | 1.5 Millimole per liter (mmol/L) | Standard Deviation 4.09 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 56, n=62 | 2.2 Millimole per liter (mmol/L) | Standard Deviation 3.21 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 60, n=69 | 1.6 Millimole per liter (mmol/L) | Standard Deviation 3.46 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 64, n=49 | 2.3 Millimole per liter (mmol/L) | Standard Deviation 3.63 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 68, n=42 | 2.8 Millimole per liter (mmol/L) | Standard Deviation 3.64 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 72, n=52 | 2.5 Millimole per liter (mmol/L) | Standard Deviation 3.6 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 76, n=30 | 3.7 Millimole per liter (mmol/L) | Standard Deviation 3.43 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 80, n=22 | 3.5 Millimole per liter (mmol/L) | Standard Deviation 4.15 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 84, n=34 | 2.9 Millimole per liter (mmol/L) | Standard Deviation 4.04 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 88, n=15 | 3.4 Millimole per liter (mmol/L) | Standard Deviation 3.18 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 92, n=15 | 2.8 Millimole per liter (mmol/L) | Standard Deviation 2.46 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 96, n=18 | 2.9 Millimole per liter (mmol/L) | Standard Deviation 2.24 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 100, n=6 | 3.5 Millimole per liter (mmol/L) | Standard Deviation 4.09 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 104, n=1 | 8.0 Millimole per liter (mmol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Na, Mon 108, n=9 | 3.8 Millimole per liter (mmol/L) | Standard Deviation 4.35 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 3, n=10 | 0.533 Millimole per liter (mmol/L) | Standard Deviation 0.5127 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 9, n=8 | 0.846 Millimole per liter (mmol/L) | Standard Deviation 1.1121 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 12, n=13 | 0.713 Millimole per liter (mmol/L) | Standard Deviation 0.8743 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 48, n=5 | 0.712 Millimole per liter (mmol/L) | Standard Deviation 1.1305 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 60, n=5 | 1.282 Millimole per liter (mmol/L) | Standard Deviation 1.7228 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Urea, Mon 76, n=3 | 1.070 Millimole per liter (mmol/L) | Standard Deviation 0.943 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 80, n=22 | 2.2 Millimole per liter (mmol/L) | Standard Deviation 3.74 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 84, n=34 | 3.0 Millimole per liter (mmol/L) | Standard Deviation 5.49 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 88, n=15 | 1.7 Millimole per liter (mmol/L) | Standard Deviation 2.09 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Bicarbonate, Mon 100, n=6 | -0.7 Millimole per liter (mmol/L) | Standard Deviation 1.86 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 1, n=170 | 1.3 Millimole per liter (mmol/L) | Standard Deviation 3.38 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 88, n=15 | 2.2 Millimole per liter (mmol/L) | Standard Deviation 2.31 |
| Overall Study | Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea | Cl, Mon 100, n=6 | 1.8 Millimole per liter (mmol/L) | Standard Deviation 4.26 |
Primary
Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)
Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 1, n=170 | 3 Micromole per Liter (umol/L) | Standard Deviation 12.2 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 3, n=149 | 4 Micromole per Liter (umol/L) | Standard Deviation 13.74 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 6, n=133 | 4.9 Micromole per Liter (umol/L) | Standard Deviation 13.47 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 9, n=120 | 3.7 Micromole per Liter (umol/L) | Standard Deviation 14.88 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 12, n=167 | 4.5 Micromole per Liter (umol/L) | Standard Deviation 13.91 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 16, n=100 | 4.0 Micromole per Liter (umol/L) | Standard Deviation 15.25 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 20, n=94 | 3.0 Micromole per Liter (umol/L) | Standard Deviation 15.67 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 24, n=105 | 1.9 Micromole per Liter (umol/L) | Standard Deviation 17.15 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 28, n=86 | -1.0 Micromole per Liter (umol/L) | Standard Deviation 13.98 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 36, n=88 | -0.9 Micromole per Liter (umol/L) | Standard Deviation 14.9 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 40, n=75 | 0.1 Micromole per Liter (umol/L) | Standard Deviation 14.38 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 56, n=62 | 1.2 Micromole per Liter (umol/L) | Standard Deviation 11.42 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 60, n=69 | -0.2 Micromole per Liter (umol/L) | Standard Deviation 15.54 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 96, n=18 | 1.2 Micromole per Liter (umol/L) | Standard Deviation 10.86 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 6, n=134 | 3.8 Micromole per Liter (umol/L) | Standard Deviation 4.04 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 9, n=120 | 3.6 Micromole per Liter (umol/L) | Standard Deviation 4.4 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 12, n=167 | 2.7 Micromole per Liter (umol/L) | Standard Deviation 4.1 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 28, n=87 | 2.8 Micromole per Liter (umol/L) | Standard Deviation 4.26 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 32, n=85 | 2.4 Micromole per Liter (umol/L) | Standard Deviation 4.95 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 36, n=89 | 2.2 Micromole per Liter (umol/L) | Standard Deviation 4.26 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 40, n=77 | 2.7 Micromole per Liter (umol/L) | Standard Deviation 4.68 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 44, n=73 | 2.6 Micromole per Liter (umol/L) | Standard Deviation 4.33 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 48, n=78 | 2.2 Micromole per Liter (umol/L) | Standard Deviation 4.98 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 52, n=67 | 2.0 Micromole per Liter (umol/L) | Standard Deviation 4.75 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 56, n=62 | 2.1 Micromole per Liter (umol/L) | Standard Deviation 4.54 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 60, n=68 | 2.1 Micromole per Liter (umol/L) | Standard Deviation 4.75 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 84, n=34 | -0.3 Micromole per Liter (umol/L) | Standard Deviation 4.09 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 88, n=15 | 2.1 Micromole per Liter (umol/L) | Standard Deviation 7.05 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 92, n=15 | 1.3 Micromole per Liter (umol/L) | Standard Deviation 4.89 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 96, n=18 | -0.2 Micromole per Liter (umol/L) | Standard Deviation 5.06 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 100, n=6 | 1.2 Micromole per Liter (umol/L) | Standard Deviation 4.49 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 104, n=1 | 9.0 Micromole per Liter (umol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 108, n=9 | -0.3 Micromole per Liter (umol/L) | Standard Deviation 2.24 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 6, n=137 | 2.9 Micromole per Liter (umol/L) | Standard Deviation 44.98 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 9, n=123 | 4.5 Micromole per Liter (umol/L) | Standard Deviation 48.74 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 12, n=169 | 6.6 Micromole per Liter (umol/L) | Standard Deviation 50.88 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 16, n=100 | 2.5 Micromole per Liter (umol/L) | Standard Deviation 55.01 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 20, n=97 | 2.3 Micromole per Liter (umol/L) | Standard Deviation 49.72 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 24, n=109 | 4.7 Micromole per Liter (umol/L) | Standard Deviation 53.68 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 28, n=87 | 12.2 Micromole per Liter (umol/L) | Standard Deviation 51.73 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 32, n=85 | 10.2 Micromole per Liter (umol/L) | Standard Deviation 48.23 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 36, n=89 | 5.3 Micromole per Liter (umol/L) | Standard Deviation 52.19 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 40, n=77 | 6.9 Micromole per Liter (umol/L) | Standard Deviation 45.4 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 44, n=73 | 4.3 Micromole per Liter (umol/L) | Standard Deviation 53.75 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 48, n=79 | 5.7 Micromole per Liter (umol/L) | Standard Deviation 45.68 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 52, n=67 | 4.2 Micromole per Liter (umol/L) | Standard Deviation 52.86 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 56, n=62 | 8.6 Micromole per Liter (umol/L) | Standard Deviation 42.81 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 60, n=69 | 8.1 Micromole per Liter (umol/L) | Standard Deviation 49.74 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 64, n=49 | 2.7 Micromole per Liter (umol/L) | Standard Deviation 52.52 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 68, n=41 | 5.4 Micromole per Liter (umol/L) | Standard Deviation 52.49 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 72, n=51 | 12.6 Micromole per Liter (umol/L) | Standard Deviation 56.31 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 76, n=30 | 11.9 Micromole per Liter (umol/L) | Standard Deviation 53.61 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 80, n=22 | 7.0 Micromole per Liter (umol/L) | Standard Deviation 50.68 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 84, n=34 | 5.7 Micromole per Liter (umol/L) | Standard Deviation 58.19 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 88, n=15 | 3.1 Micromole per Liter (umol/L) | Standard Deviation 57.81 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 92, n=15 | -6.0 Micromole per Liter (umol/L) | Standard Deviation 60.45 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 96, n=18 | 5.3 Micromole per Liter (umol/L) | Standard Deviation 52.95 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 100, n=6 | 35.7 Micromole per Liter (umol/L) | Standard Deviation 62.78 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 104, n=1 | 107.0 Micromole per Liter (umol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 108, n=9 | 17.9 Micromole per Liter (umol/L) | Standard Deviation 59.95 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 64, n=49 | 0.6 Micromole per Liter (umol/L) | Standard Deviation 15.19 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 68, n=39 | 0.7 Micromole per Liter (umol/L) | Standard Deviation 14.31 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 72, n=51 | 0.1 Micromole per Liter (umol/L) | Standard Deviation 14.35 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 76, n=30 | 0.5 Micromole per Liter (umol/L) | Standard Deviation 14.75 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 80, n=22 | 3.3 Micromole per Liter (umol/L) | Standard Deviation 13.38 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 84, n=34 | 1.6 Micromole per Liter (umol/L) | Standard Deviation 18.72 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 88, n=15 | 1.2 Micromole per Liter (umol/L) | Standard Deviation 12.37 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 92, n=15 | 4.3 Micromole per Liter (umol/L) | Standard Deviation 12.45 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 100, n=6 | 6.2 Micromole per Liter (umol/L) | Standard Deviation 12.06 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 104, n=1 | 9.0 Micromole per Liter (umol/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 108, n=9 | 5.3 Micromole per Liter (umol/L) | Standard Deviation 14.4 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 1, n=167 | 4.6 Micromole per Liter (umol/L) | Standard Deviation 4.06 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 3, n=150 | 4.5 Micromole per Liter (umol/L) | Standard Deviation 4.34 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 16, n=100 | 3.6 Micromole per Liter (umol/L) | Standard Deviation 4.41 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 20, n=97 | 3.7 Micromole per Liter (umol/L) | Standard Deviation 3.89 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 24, n=109 | 2.6 Micromole per Liter (umol/L) | Standard Deviation 4.1 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 64, n=48 | 1.6 Micromole per Liter (umol/L) | Standard Deviation 4.56 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 68, n=41 | 1.2 Micromole per Liter (umol/L) | Standard Deviation 4.97 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 72, n=51 | 0.8 Micromole per Liter (umol/L) | Standard Deviation 4.64 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 76, n=29 | 1.0 Micromole per Liter (umol/L) | Standard Deviation 4.38 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | TB Mon 80, n=22 | 1.3 Micromole per Liter (umol/L) | Standard Deviation 3.69 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 1, n=170 | 0.8 Micromole per Liter (umol/L) | Standard Deviation 39.49 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | UA Mon 3, n=152 | 3.1 Micromole per Liter (umol/L) | Standard Deviation 47.06 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 32, n=84 | 0.0 Micromole per Liter (umol/L) | Standard Deviation 16.6 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 44, n=73 | -1.0 Micromole per Liter (umol/L) | Standard Deviation 13.93 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 48, n=79 | -0.2 Micromole per Liter (umol/L) | Standard Deviation 15.16 |
| Overall Study | Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) | Creatinine, Mon 52, n=67 | 0.1 Micromole per Liter (umol/L) | Standard Deviation 14.84 |
Primary
Change From Baseline in Chemistry Parameter-Total Protein
Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 1, n=170 | -1.1 Grams per liter (g/L) | Standard Deviation 4.44 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 3, n=152 | -0.5 Grams per liter (g/L) | Standard Deviation 4.87 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 12, n=169 | 0.2 Grams per liter (g/L) | Standard Deviation 4.45 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 16, n=100 | 0.3 Grams per liter (g/L) | Standard Deviation 5.15 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 20, n=97 | 0.8 Grams per liter (g/L) | Standard Deviation 4.64 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 24, n=109 | 0.2 Grams per liter (g/L) | Standard Deviation 4.67 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 28, n=87 | -0.2 Grams per liter (g/L) | Standard Deviation 4.52 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 32, n=85 | 0.1 Grams per liter (g/L) | Standard Deviation 4.55 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 36, n=89 | -1.1 Grams per liter (g/L) | Standard Deviation 4.48 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 40, n=77 | -1.1 Grams per liter (g/L) | Standard Deviation 4.46 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 44, n=73 | -0.1 Grams per liter (g/L) | Standard Deviation 4.72 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 48, n=79 | -1.3 Grams per liter (g/L) | Standard Deviation 4.34 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 52, n=67 | -0.7 Grams per liter (g/L) | Standard Deviation 4.67 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 56, n=62 | -1.1 Grams per liter (g/L) | Standard Deviation 4.32 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 60, n=69 | -0.7 Grams per liter (g/L) | Standard Deviation 4.75 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 64, n=49 | -0.2 Grams per liter (g/L) | Standard Deviation 4.86 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 68, n=41 | 0.6 Grams per liter (g/L) | Standard Deviation 4.82 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 72, n=51 | -0.7 Grams per liter (g/L) | Standard Deviation 5.17 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 76, n=30 | 0.8 Grams per liter (g/L) | Standard Deviation 4.93 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 80, n=22 | 0.3 Grams per liter (g/L) | Standard Deviation 4.82 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 84, n=34 | 0.7 Grams per liter (g/L) | Standard Deviation 5.9 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 88, n=15 | 0.4 Grams per liter (g/L) | Standard Deviation 5.29 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 92, n=15 | 1.0 Grams per liter (g/L) | Standard Deviation 4.09 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 96, n=18 | 0.9 Grams per liter (g/L) | Standard Deviation 3.2 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 100, n=6 | 2.0 Grams per liter (g/L) | Standard Deviation 4.77 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 6, n=137 | -1.0 Grams per liter (g/L) | Standard Deviation 4.77 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 9, n=123 | -0.8 Grams per liter (g/L) | Standard Deviation 4.6 |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 104, n=1 | 7.0 Grams per liter (g/L) | — |
| Overall Study | Change From Baseline in Chemistry Parameter-Total Protein | TP Mon 108, n=9 | 2.1 Grams per liter (g/L) | Standard Deviation 4.94 |
Primary
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 1, n=167 | -1.3 Degree | Standard Deviation 14.34 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 3, n=151 | -2.9 Degree | Standard Deviation 15.94 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 6, n=134 | -1.5 Degree | Standard Deviation 11.5 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 9, n=118 | -2.3 Degree | Standard Deviation 11.8 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 12, n=160 | -3.1 Degree | Standard Deviation 13.72 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 24, n=104 | -1.9 Degree | Standard Deviation 13.03 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 36, n=87 | -2.5 Degree | Standard Deviation 11.43 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 48, n=77 | -3.4 Degree | Standard Deviation 19.82 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 60, n=68 | -8.0 Degree | Standard Deviation 14.5 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 108, n=10 | -7.0 Degree | Standard Deviation 8.81 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 72, n=52 | -4.0 Degree | Standard Deviation 12.31 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 84, n=34 | -4.1 Degree | Standard Deviation 16.09 |
| Overall Study | Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis | QRS axis, Mon 96, n=18 | -4.9 Degree | Standard Deviation 8.53 |
Primary
Change From Baseline in Haematocrit
Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 4, n=26 | -0.012 Volume/Volume (v/v) | Standard Deviation 0.0293 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 6, n=136 | -0.004 Volume/Volume (v/v) | Standard Deviation 0.0262 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 8, n=41 | -0.005 Volume/Volume (v/v) | Standard Deviation 0.0248 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 9, n=120 | -0.006 Volume/Volume (v/v) | Standard Deviation 0.0272 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 10, n=55 | -0.002 Volume/Volume (v/v) | Standard Deviation 0.0295 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 12, n=162 | -0.001 Volume/Volume (v/v) | Standard Deviation 0.0291 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 16, n=98 | -0.005 Volume/Volume (v/v) | Standard Deviation 0.0292 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 20, n=94 | -0.001 Volume/Volume (v/v) | Standard Deviation 0.028 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 48, n=76 | -0.009 Volume/Volume (v/v) | Standard Deviation 0.0376 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 52, n=67 | 0.001 Volume/Volume (v/v) | Standard Deviation 0.0347 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 56, n=62 | -0.001 Volume/Volume (v/v) | Standard Deviation 0.0335 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 64, n=49 | 0.004 Volume/Volume (v/v) | Standard Deviation 0.0332 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 68, n=44 | 0.011 Volume/Volume (v/v) | Standard Deviation 0.0345 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 72, n=53 | 0.008 Volume/Volume (v/v) | Standard Deviation 0.0346 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 76, n=31 | 0.014 Volume/Volume (v/v) | Standard Deviation 0.035 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 80, n=23 | 0.009 Volume/Volume (v/v) | Standard Deviation 0.0272 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 84, n=34 | 0.007 Volume/Volume (v/v) | Standard Deviation 0.0379 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 88, n=16 | 0.017 Volume/Volume (v/v) | Standard Deviation 0.0332 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 92, n=14 | 0.027 Volume/Volume (v/v) | Standard Deviation 0.0267 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 96, n=18 | 0.017 Volume/Volume (v/v) | Standard Deviation 0.0311 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 100, n=6 | 0.028 Volume/Volume (v/v) | Standard Deviation 0.0232 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 1, n=165 | -0.009 Volume/Volume (v/v) | Standard Deviation 0.0272 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 2, n=15 | -0.001 Volume/Volume (v/v) | Standard Deviation 0.021 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 3, n=153 | -0.007 Volume/Volume (v/v) | Standard Deviation 0.0287 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 24, n=109 | -0.002 Volume/Volume (v/v) | Standard Deviation 0.0267 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 28, n=84 | -0.004 Volume/Volume (v/v) | Standard Deviation 0.025 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 32, n=85 | -0.001 Volume/Volume (v/v) | Standard Deviation 0.0273 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 36, n=91 | -0.005 Volume/Volume (v/v) | Standard Deviation 0.0298 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 40, n=77 | -0.004 Volume/Volume (v/v) | Standard Deviation 0.0319 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 44, n=73 | -0.002 Volume/Volume (v/v) | Standard Deviation 0.0287 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 60, n=71 | 0.005 Volume/Volume (v/v) | Standard Deviation 0.0352 |
| Overall Study | Change From Baseline in Haematocrit | Haematocrit, Mon 108, n=9 | 0.030 Volume/Volume (v/v) | Standard Deviation 0.0283 |
Primary
Change From Baseline in Haemoglobin
Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 1, n=169 | -3.2 Grams/Liter (g/L) | Standard Deviation 8.97 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 2, n=15 | -0.9 Grams/Liter (g/L) | Standard Deviation 7.26 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 3, n=154 | -2.6 Grams/Liter (g/L) | Standard Deviation 9.41 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 6, n=137 | -2.2 Grams/Liter (g/L) | Standard Deviation 9.31 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 8, n=43 | -1.9 Grams/Liter (g/L) | Standard Deviation 9.4 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 9, n=122 | -2.9 Grams/Liter (g/L) | Standard Deviation 9.45 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 10, n=55 | -0.9 Grams/Liter (g/L) | Standard Deviation 9.26 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 12, n=167 | -0.7 Grams/Liter (g/L) | Standard Deviation 9.61 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 16, n=98 | -2.5 Grams/Liter (g/L) | Standard Deviation 9.96 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 20, n=96 | -1.4 Grams/Liter (g/L) | Standard Deviation 9.34 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 24, n=110 | -2.2 Grams/Liter (g/L) | Standard Deviation 8.76 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 28, n=85 | -3.2 Grams/Liter (g/L) | Standard Deviation 9.49 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 32, n=86 | -2.2 Grams/Liter (g/L) | Standard Deviation 8.84 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 36, n=91 | -3.3 Grams/Liter (g/L) | Standard Deviation 10.04 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 40, n=78 | -3.4 Grams/Liter (g/L) | Standard Deviation 10.88 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 68, n=44 | -2.0 Grams/Liter (g/L) | Standard Deviation 10.41 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 72, n=53 | -3.8 Grams/Liter (g/L) | Standard Deviation 11.03 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 76, n=31 | -3.1 Grams/Liter (g/L) | Standard Deviation 11.65 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 80, n=24 | -3.7 Grams/Liter (g/L) | Standard Deviation 9.24 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 84, n=35 | -3.8 Grams/Liter (g/L) | Standard Deviation 11.97 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 88, n=16 | -3.1 Grams/Liter (g/L) | Standard Deviation 9.76 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 4, n=26 | -5.7 Grams/Liter (g/L) | Standard Deviation 10.44 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 44, n=74 | -2.3 Grams/Liter (g/L) | Standard Deviation 9.74 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 48, n=79 | -4.3 Grams/Liter (g/L) | Standard Deviation 11.13 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 52, n=68 | -2.0 Grams/Liter (g/L) | Standard Deviation 9.51 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 56, n=63 | -2.8 Grams/Liter (g/L) | Standard Deviation 9.33 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 60, n=71 | -2.9 Grams/Liter (g/L) | Standard Deviation 10.15 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 64, n=49 | -3.7 Grams/Liter (g/L) | Standard Deviation 10.55 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 92, n=15 | 0.7 Grams/Liter (g/L) | Standard Deviation 9.14 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 96, n=19 | -2.1 Grams/Liter (g/L) | Standard Deviation 7.57 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 100, n=7 | 2.6 Grams/Liter (g/L) | Standard Deviation 8.87 |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 104, n=1 | 8.0 Grams/Liter (g/L) | — |
| Overall Study | Change From Baseline in Haemoglobin | Haemoglobin, Mon 108, n=10 | 0.5 Grams/Liter (g/L) | Standard Deviation 7.47 |
Primary
Change From Baseline in Heart Rate
Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 48, n=82 | -2.1 Beats per Minute | Standard Deviation 11.25 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 3, n=159 | -0.7 Beats per Minute | Standard Deviation 11.34 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 6, n=143 | -0.2 Beats per Minute | Standard Deviation 11.57 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 12, n=173 | -0.1 Beats per Minute | Standard Deviation 12.02 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 16, n=104 | 1.1 Beats per Minute | Standard Deviation 12.51 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 20, n=100 | 1.1 Beats per Minute | Standard Deviation 12.1 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 24, n=112 | -0.1 Beats per Minute | Standard Deviation 15.92 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 28, n=88 | -0.8 Beats per Minute | Standard Deviation 13.11 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 32, n=85 | 0.4 Beats per Minute | Standard Deviation 12.56 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 36, n=92 | -1.7 Beats per Minute | Standard Deviation 11.38 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 40, n=78 | -0.6 Beats per Minute | Standard Deviation 13.28 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 44, n=76 | -2.8 Beats per Minute | Standard Deviation 12.47 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 52, n=67 | -1.5 Beats per Minute | Standard Deviation 11.39 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 60, n=70 | -1.2 Beats per Minute | Standard Deviation 12.89 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 64, n=50 | -2.1 Beats per Minute | Standard Deviation 11.54 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 68, n=45 | 1.2 Beats per Minute | Standard Deviation 13.87 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 72, n=57 | -1.9 Beats per Minute | Standard Deviation 12.32 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 76, n=31 | -1.6 Beats per Minute | Standard Deviation 13.05 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 80, n=24 | -2.2 Beats per Minute | Standard Deviation 11.93 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 84, n=36 | -2.4 Beats per Minute | Standard Deviation 12.56 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 88, n=17 | 1.5 Beats per Minute | Standard Deviation 13.98 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 92, n=16 | -2.7 Beats per Minute | Standard Deviation 11.52 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 96, n=19 | -1.0 Beats per Minute | Standard Deviation 14.35 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 100, n=7 | -8.3 Beats per Minute | Standard Deviation 19.1 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 104, n=1 | -6.0 Beats per Minute | — |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 108, n=10 | -3.4 Beats per Minute | Standard Deviation 12.86 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 1, n=174 | 0.7 Beats per Minute | Standard Deviation 11.97 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 3, n=158 | 1.0 Beats per Minute | Standard Deviation 12.02 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 6, n=143 | 1.6 Beats per Minute | Standard Deviation 12.82 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 9, n=124 | 1.1 Beats per Minute | Standard Deviation 12.99 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 12, n=170 | 2.3 Beats per Minute | Standard Deviation 12.64 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 16, n=104 | 2.5 Beats per Minute | Standard Deviation 12.71 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 20, n=100 | 0.2 Beats per Minute | Standard Deviation 13.35 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 24, n=110 | 2.6 Beats per Minute | Standard Deviation 17.38 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 28, n=87 | -0.8 Beats per Minute | Standard Deviation 13.79 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 32, n=84 | 1.7 Beats per Minute | Standard Deviation 11.71 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 36, n=91 | -0.4 Beats per Minute | Standard Deviation 12.4 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 40, n=77 | 0.4 Beats per Minute | Standard Deviation 11.51 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 44, n=75 | -0.3 Beats per Minute | Standard Deviation 12.74 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 48, n=81 | -1.9 Beats per Minute | Standard Deviation 12.57 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 52, n=67 | -0.3 Beats per Minute | Standard Deviation 12.71 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 56, n=62 | 1.3 Beats per Minute | Standard Deviation 12.21 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 60, n=69 | -0.2 Beats per Minute | Standard Deviation 14.44 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 64, n=49 | 1.3 Beats per Minute | Standard Deviation 14.29 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 68, n=45 | 4.1 Beats per Minute | Standard Deviation 14.77 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 72, n=56 | 0.4 Beats per Minute | Standard Deviation 12.1 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 76, n=30 | 1.9 Beats per Minute | Standard Deviation 13.26 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 80, n=23 | 3.0 Beats per Minute | Standard Deviation 11.81 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 84, n=35 | 0.2 Beats per Minute | Standard Deviation 13.24 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 92, n=16 | 3.1 Beats per Minute | Standard Deviation 10.13 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 96, n=19 | 3.2 Beats per Minute | Standard Deviation 13.12 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 100, n=7 | 2.6 Beats per Minute | Standard Deviation 10.72 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 104, n=1 | 0.0 Beats per Minute | — |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 108, n=10 | -5.4 Beats per Minute | Standard Deviation 11.37 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 1, n=174 | -1.0 Beats per Minute | Standard Deviation 10.21 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 9, n=124 | -1.0 Beats per Minute | Standard Deviation 11.33 |
| Overall Study | Change From Baseline in Heart Rate | Su HR Mon 56, n=63 | -1.8 Beats per Minute | Standard Deviation 12.3 |
| Overall Study | Change From Baseline in Heart Rate | St HR Mon 88, n=17 | 3.6 Beats per Minute | Standard Deviation 12.24 |
Primary
Change From Baseline in Hematology Parameter-Red Blood Cell Count
Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 1, n=169 | -0.09 10^12 cells/Liter(L) | Standard Deviation 0.281 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 2, n=15 | 0.01 10^12 cells/Liter(L) | Standard Deviation 0.222 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 4, n=26 | -0.16 10^12 cells/Liter(L) | Standard Deviation 0.305 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 6, n=137 | -0.04 10^12 cells/Liter(L) | Standard Deviation 0.287 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 12, n=167 | 0.00 10^12 cells/Liter(L) | Standard Deviation 0.291 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 16, n=99 | -0.04 10^12 cells/Liter(L) | Standard Deviation 0.32 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 20, n=96 | 0.01 10^12 cells/Liter(L) | Standard Deviation 0.329 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 24, n=110 | -0.01 10^12 cells/Liter(L) | Standard Deviation 0.29 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 28, n=85 | -0.04 10^12 cells/Liter(L) | Standard Deviation 0.324 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 32, n=86 | -0.03 10^12 cells/Liter(L) | Standard Deviation 0.322 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 36, n=91 | -0.11 10^12 cells/Liter(L) | Standard Deviation 0.288 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 40, n=78 | -0.11 10^12 cells/Liter(L) | Standard Deviation 0.32 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 44, n=74 | -0.09 10^12 cells/Liter(L) | Standard Deviation 0.318 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 48, n=79 | -0.16 10^12 cells/Liter(L) | Standard Deviation 0.316 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 52, n=68 | -0.08 10^12 cells/Liter(L) | Standard Deviation 0.336 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 56, n=63 | -0.13 10^12 cells/Liter(L) | Standard Deviation 0.272 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 60, n=71 | -0.14 10^12 cells/Liter(L) | Standard Deviation 0.317 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 64, n=49 | -0.10 10^12 cells/Liter(L) | Standard Deviation 0.323 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 68, n=44 | -0.06 10^12 cells/Liter(L) | Standard Deviation 0.326 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 72, n=53 | -0.09 10^12 cells/Liter(L) | Standard Deviation 0.363 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 76, n=31 | 0.00 10^12 cells/Liter(L) | Standard Deviation 0.373 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 80, n=24 | -0.03 10^12 cells/Liter(L) | Standard Deviation 0.343 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 84, n=35 | -0.00 10^12 cells/Liter(L) | Standard Deviation 0.379 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 88, n=16 | 0.03 10^12 cells/Liter(L) | Standard Deviation 0.353 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 92, n=15 | 0.14 10^12 cells/Liter(L) | Standard Deviation 0.3 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 96, n=19 | 0.04 10^12 cells/Liter(L) | Standard Deviation 0.248 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 100, n=7 | 0.23 10^12 cells/Liter(L) | Standard Deviation 0.287 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 104, n=1 | 0.30 10^12 cells/Liter(L) | — |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 108, n=10 | 0.15 10^12 cells/Liter(L) | Standard Deviation 0.207 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 3, n=154 | -0.06 10^12 cells/Liter(L) | Standard Deviation 0.309 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 8, n=43 | -0.03 10^12 cells/Liter(L) | Standard Deviation 0.312 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 9, n=122 | -0.06 10^12 cells/Liter(L) | Standard Deviation 0.294 |
| Overall Study | Change From Baseline in Hematology Parameter-Red Blood Cell Count | RBC, Mon 10, n=55 | -0.01 10^12 cells/Liter(L) | Standard Deviation 0.299 |
Primary
Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)
Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Bands, Mon 1, n=2 | -0.135 10^9 cells/Liter | Standard Deviation 0.1768 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Bands, Mon 9, n=2 | -0.205 10^9 cells/Liter | Standard Deviation 0.6576 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Bands, Mon 20, n=2 | -0.095 10^9 cells/Liter | Standard Deviation 0.1202 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 2, n=15 | -0.015 10^9 cells/Liter | Standard Deviation 0.0307 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 3, n=153 | 0.001 10^9 cells/Liter | Standard Deviation 0.0274 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 4, n=26 | -0.002 10^9 cells/Liter | Standard Deviation 0.0199 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 8, n=42 | 0.002 10^9 cells/Liter | Standard Deviation 0.0258 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 9, n=121 | 0.003 10^9 cells/Liter | Standard Deviation 0.0274 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 10, n=54 | 0.001 10^9 cells/Liter | Standard Deviation 0.0241 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 12, n=165 | 0.001 10^9 cells/Liter | Standard Deviation 0.0298 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 16, n=96 | 0.005 10^9 cells/Liter | Standard Deviation 0.0288 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 24, n=109 | 0.008 10^9 cells/Liter | Standard Deviation 0.0289 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 28, n=84 | 0.005 10^9 cells/Liter | Standard Deviation 0.0289 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 32, n=81 | 0.005 10^9 cells/Liter | Standard Deviation 0.0301 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 40, n=74 | 0.004 10^9 cells/Liter | Standard Deviation 0.0243 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 44, n=72 | 0.004 10^9 cells/Liter | Standard Deviation 0.02 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 48, n=77 | 0.004 10^9 cells/Liter | Standard Deviation 0.0313 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 52, n=65 | -0.004 10^9 cells/Liter | Standard Deviation 0.0227 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 56, n=63 | -0.004 10^9 cells/Liter | Standard Deviation 0.0234 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 60, n=71 | -0.003 10^9 cells/Liter | Standard Deviation 0.0238 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 64, n=49 | -0.003 10^9 cells/Liter | Standard Deviation 0.0195 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 80, n=24 | -0.001 10^9 cells/Liter | Standard Deviation 0.0198 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 84, n=33 | 0.002 10^9 cells/Liter | Standard Deviation 0.0238 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 96, n=19 | 0.006 10^9 cells/Liter | Standard Deviation 0.0257 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 104, n=1 | -0.020 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 108, n=10 | 0.012 10^9 cells/Liter | Standard Deviation 0.021 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 1, n=168 | -0.008 10^9 cells/Liter | Standard Deviation 0.1009 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 2, n=15 | 0.023 10^9 cells/Liter | Standard Deviation 0.0948 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 4, n=26 | -0.003 10^9 cells/Liter | Standard Deviation 0.1236 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 6, n=137 | -0.015 10^9 cells/Liter | Standard Deviation 0.1208 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 8, n=42 | -0.022 10^9 cells/Liter | Standard Deviation 0.1078 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 9, n=121 | -0.010 10^9 cells/Liter | Standard Deviation 0.1166 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 10, n=54 | 0.000 10^9 cells/Liter | Standard Deviation 0.1083 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 12, n=165 | -0.019 10^9 cells/Liter | Standard Deviation 0.0943 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 16, n=96 | -0.006 10^9 cells/Liter | Standard Deviation 0.1145 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 24, n=109 | -0.002 10^9 cells/Liter | Standard Deviation 0.1108 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 28, n=84 | -0.016 10^9 cells/Liter | Standard Deviation 0.1114 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 32, n=81 | 0.001 10^9 cells/Liter | Standard Deviation 0.1192 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 36, n=91 | -0.006 10^9 cells/Liter | Standard Deviation 0.1026 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 40, n=74 | -0.004 10^9 cells/Liter | Standard Deviation 0.1165 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 44, n=72 | -0.014 10^9 cells/Liter | Standard Deviation 0.1158 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 48, n=77 | -0.002 10^9 cells/Liter | Standard Deviation 0.123 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 52, n=65 | -0.011 10^9 cells/Liter | Standard Deviation 0.1137 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 56, n=63 | -0.002 10^9 cells/Liter | Standard Deviation 0.1251 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 64, n=49 | -0.008 10^9 cells/Liter | Standard Deviation 0.0989 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 68, n=43 | -0.000 10^9 cells/Liter | Standard Deviation 0.1122 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 72, n=53 | 0.005 10^9 cells/Liter | Standard Deviation 0.1049 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 76, n=31 | -0.003 10^9 cells/Liter | Standard Deviation 0.1102 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 80, n=24 | -0.010 10^9 cells/Liter | Standard Deviation 0.0837 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 84, n=33 | -0.000 10^9 cells/Liter | Standard Deviation 0.1105 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 88, n=16 | 0.030 10^9 cells/Liter | Standard Deviation 0.0602 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 92, n=15 | 0.006 10^9 cells/Liter | Standard Deviation 0.0631 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 96, n=19 | 0.018 10^9 cells/Liter | Standard Deviation 0.0511 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 100, n=7 | 0.033 10^9 cells/Liter | Standard Deviation 0.093 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 104, n=1 | 0.030 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 108, n=10 | -0.005 10^9 cells/Liter | Standard Deviation 0.0792 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 1, n=168 | -0.178 10^9 cells/Liter | Standard Deviation 0.4512 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 2, n=15 | -0.043 10^9 cells/Liter | Standard Deviation 0.6364 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 3, n=153 | -0.134 10^9 cells/Liter | Standard Deviation 0.4336 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 4, n=26 | 0.054 10^9 cells/Liter | Standard Deviation 0.3529 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 6, n=137 | -0.055 10^9 cells/Liter | Standard Deviation 0.4415 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 8, n=42 | 0.168 10^9 cells/Liter | Standard Deviation 0.7157 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 10, n=54 | 0.120 10^9 cells/Liter | Standard Deviation 0.5265 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 12, n=165 | 0.009 10^9 cells/Liter | Standard Deviation 0.5438 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 16, n=96 | -0.053 10^9 cells/Liter | Standard Deviation 0.5393 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 20, n=92 | -0.031 10^9 cells/Liter | Standard Deviation 0.5364 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 24, n=109 | -0.069 10^9 cells/Liter | Standard Deviation 0.4973 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 28, n=84 | -0.077 10^9 cells/Liter | Standard Deviation 0.5271 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 32, n=81 | 0.013 10^9 cells/Liter | Standard Deviation 0.592 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 36, n=91 | -0.055 10^9 cells/Liter | Standard Deviation 0.4798 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 48, n=77 | 0.061 10^9 cells/Liter | Standard Deviation 0.5921 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 52, n=65 | -0.049 10^9 cells/Liter | Standard Deviation 0.4875 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 56, n=63 | -0.065 10^9 cells/Liter | Standard Deviation 0.5298 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 60, n=71 | -0.025 10^9 cells/Liter | Standard Deviation 0.5503 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 64, n=49 | -0.011 10^9 cells/Liter | Standard Deviation 0.5106 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 68, n=43 | -0.002 10^9 cells/Liter | Standard Deviation 0.6027 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 72, n=53 | -0.052 10^9 cells/Liter | Standard Deviation 0.541 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 76, n=31 | 0.104 10^9 cells/Liter | Standard Deviation 0.6589 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 80, n=24 | 0.149 10^9 cells/Liter | Standard Deviation 0.6626 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 84, n=33 | 0.154 10^9 cells/Liter | Standard Deviation 0.6009 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 88, n=16 | 0.189 10^9 cells/Liter | Standard Deviation 0.4887 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 92, n=15 | 0.405 10^9 cells/Liter | Standard Deviation 0.5963 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 96, n=19 | 0.285 10^9 cells/Liter | Standard Deviation 0.617 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 100, n=7 | 0.144 10^9 cells/Liter | Standard Deviation 0.4465 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 104, n=1 | 0.000 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 108, n=10 | 0.044 10^9 cells/Liter | Standard Deviation 0.5883 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Metamyelocyte, Mon 3, n=1 | -0.010 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 1, n=168 | 0.006 10^9 cells/Liter | Standard Deviation 0.1755 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 2, n=15 | 0.002 10^9 cells/Liter | Standard Deviation 0.2583 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 3, n=153 | 0.016 10^9 cells/Liter | Standard Deviation 0.173 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 6, n=137 | -0.001 10^9 cells/Liter | Standard Deviation 0.1628 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 8, n=42 | 0.033 10^9 cells/Liter | Standard Deviation 0.2 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 16, n=96 | -0.021 10^9 cells/Liter | Standard Deviation 0.1651 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 56, n=63 | -0.035 10^9 cells/Liter | Standard Deviation 0.1776 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 60, n=71 | -0.013 10^9 cells/Liter | Standard Deviation 0.172 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 68, n=43 | 0.003 10^9 cells/Liter | Standard Deviation 0.1491 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 72, n=53 | -0.007 10^9 cells/Liter | Standard Deviation 0.1704 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 76, n=31 | 0.038 10^9 cells/Liter | Standard Deviation 0.1456 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 80, n=24 | 0.019 10^9 cells/Liter | Standard Deviation 0.1473 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 88, n=16 | -0.006 10^9 cells/Liter | Standard Deviation 0.1699 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 92, n=15 | 0.029 10^9 cells/Liter | Standard Deviation 0.1737 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 96, n=19 | 0.035 10^9 cells/Liter | Standard Deviation 0.1437 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 100, n=7 | 0.004 10^9 cells/Liter | Standard Deviation 0.1274 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 104, n=1 | 0.070 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 3, n=153 | 0.211 10^9 cells/Liter | Standard Deviation 1.2173 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 4, n=26 | -0.003 10^9 cells/Liter | Standard Deviation 1.1181 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 6, n=137 | 0.124 10^9 cells/Liter | Standard Deviation 1.0916 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 9, n=121 | 0.074 10^9 cells/Liter | Standard Deviation 1.0966 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 10, n=54 | 0.211 10^9 cells/Liter | Standard Deviation 1.4455 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 12, n=165 | 0.309 10^9 cells/Liter | Standard Deviation 1.2657 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 20, n=92 | 0.145 10^9 cells/Liter | Standard Deviation 1.039 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 32, n=81 | -0.034 10^9 cells/Liter | Standard Deviation 1.1604 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 36, n=91 | -0.054 10^9 cells/Liter | Standard Deviation 1.0499 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 40, n=74 | 0.141 10^9 cells/Liter | Standard Deviation 1.101 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 44, n=72 | 0.003 10^9 cells/Liter | Standard Deviation 1.0641 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 48, n=77 | 0.197 10^9 cells/Liter | Standard Deviation 1.4174 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 56, n=63 | 0.075 10^9 cells/Liter | Standard Deviation 1.069 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 52, n=65 | 0.151 10^9 cells/Liter | Standard Deviation 1.1449 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 60, n=71 | 0.203 10^9 cells/Liter | Standard Deviation 1.653 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 64, n=49 | -0.042 10^9 cells/Liter | Standard Deviation 1.0603 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 72, n=53 | 0.337 10^9 cells/Liter | Standard Deviation 1.3877 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 76, n=31 | 0.380 10^9 cells/Liter | Standard Deviation 0.9556 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 80, n=24 | 0.495 10^9 cells/Liter | Standard Deviation 1.1337 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 84, n=33 | 0.735 10^9 cells/Liter | Standard Deviation 1.2746 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 88, n=16 | 0.036 10^9 cells/Liter | Standard Deviation 0.689 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 10, n=54 | 2.9 10^9 cells/Liter | Standard Deviation 39.6 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 12, n=161 | -5.2 10^9 cells/Liter | Standard Deviation 40.72 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 24, n=104 | -11.0 10^9 cells/Liter | Standard Deviation 42.31 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 48, n=77 | -16.1 10^9 cells/Liter | Standard Deviation 41.68 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 68, n=44 | -21.0 10^9 cells/Liter | Standard Deviation 48.34 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 72, n=52 | -15.7 10^9 cells/Liter | Standard Deviation 43.17 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 76, n=31 | -11.5 10^9 cells/Liter | Standard Deviation 52.19 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 84, n=35 | -4.3 10^9 cells/Liter | Standard Deviation 40.03 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 88, n=16 | -10.2 10^9 cells/Liter | Standard Deviation 30.96 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 92, n=15 | -2.9 10^9 cells/Liter | Standard Deviation 25.92 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 96, n=19 | -7.2 10^9 cells/Liter | Standard Deviation 37.84 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 100, n=7 | -14.3 10^9 cells/Liter | Standard Deviation 50.43 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 104, n=1 | -46.0 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 108, n=10 | -22.3 10^9 cells/Liter | Standard Deviation 40.89 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 1, n=169 | -0.00 10^9 cells/Liter | Standard Deviation 1.708 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 3, n=154 | 0.10 10^9 cells/Liter | Standard Deviation 1.434 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 4, n=26 | 0.17 10^9 cells/Liter | Standard Deviation 1.279 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 6, n=137 | 0.06 10^9 cells/Liter | Standard Deviation 1.235 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 8, n=43 | -0.11 10^9 cells/Liter | Standard Deviation 1.577 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 9, n=122 | 0.05 10^9 cells/Liter | Standard Deviation 1.356 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 10, n=55 | 0.33 10^9 cells/Liter | Standard Deviation 1.654 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 12, n=167 | 0.30 10^9 cells/Liter | Standard Deviation 1.5 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 16, n=99 | 0.20 10^9 cells/Liter | Standard Deviation 1.362 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 20, n=96 | 0.14 10^9 cells/Liter | Standard Deviation 1.274 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 24, n=110 | 0.16 10^9 cells/Liter | Standard Deviation 1.398 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 28, n=85 | -0.14 10^9 cells/Liter | Standard Deviation 1.303 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 32, n=86 | 0.02 10^9 cells/Liter | Standard Deviation 1.347 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 44, n=74 | -0.04 10^9 cells/Liter | Standard Deviation 1.372 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 48, n=79 | 0.24 10^9 cells/Liter | Standard Deviation 1.438 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 56, n=63 | -0.04 10^9 cells/Liter | Standard Deviation 1.198 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 64, n=49 | -0.09 10^9 cells/Liter | Standard Deviation 1.236 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 68, n=44 | 0.27 10^9 cells/Liter | Standard Deviation 1.463 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 72, n=53 | 0.27 10^9 cells/Liter | Standard Deviation 1.502 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 76, n=31 | 0.51 10^9 cells/Liter | Standard Deviation 1.252 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 80, n=24 | 0.65 10^9 cells/Liter | Standard Deviation 1.219 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 84, n=35 | 0.93 10^9 cells/Liter | Standard Deviation 1.29 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 88, n=16 | 0.25 10^9 cells/Liter | Standard Deviation 0.836 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 92, n=15 | 0.73 10^9 cells/Liter | Standard Deviation 1.348 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 96, n=19 | 0.79 10^9 cells/Liter | Standard Deviation 1.129 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 100, n=7 | 0.36 10^9 cells/Liter | Standard Deviation 0.483 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 104, n=1 | 0.30 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 108, n=10 | 0.31 10^9 cells/Liter | Standard Deviation 0.743 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 60, n=71 | 0.18 10^9 cells/Liter | Standard Deviation 1.892 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 4, n=26 | 0.039 10^9 cells/Liter | Standard Deviation 0.1759 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 9, n=121 | -0.002 10^9 cells/Liter | Standard Deviation 0.1808 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 10, n=54 | 0.029 10^9 cells/Liter | Standard Deviation 0.1686 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 12, n=165 | -0.007 10^9 cells/Liter | Standard Deviation 0.1724 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 20, n=92 | -0.009 10^9 cells/Liter | Standard Deviation 0.1573 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 24, n=109 | -0.004 10^9 cells/Liter | Standard Deviation 0.2189 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 28, n=84 | -0.031 10^9 cells/Liter | Standard Deviation 0.1759 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 32, n=81 | -0.005 10^9 cells/Liter | Standard Deviation 0.1673 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 36, n=91 | -0.039 10^9 cells/Liter | Standard Deviation 0.1821 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 40, n=74 | -0.013 10^9 cells/Liter | Standard Deviation 0.1718 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 44, n=72 | -0.037 10^9 cells/Liter | Standard Deviation 0.1807 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 48, n=77 | -0.036 10^9 cells/Liter | Standard Deviation 0.1869 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 52, n=65 | -0.026 10^9 cells/Liter | Standard Deviation 0.1743 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 64, n=49 | -0.024 10^9 cells/Liter | Standard Deviation 0.1486 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 84, n=33 | 0.065 10^9 cells/Liter | Standard Deviation 0.1555 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Monocytes, Mon 108, n=10 | 0.064 10^9 cells/Liter | Standard Deviation 0.24 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 1, n=168 | 0.158 10^9 cells/Liter | Standard Deviation 1.5462 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 2, n=15 | -0.500 10^9 cells/Liter | Standard Deviation 1.6917 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 8, n=42 | -0.427 10^9 cells/Liter | Standard Deviation 1.1287 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 16, n=96 | 0.232 10^9 cells/Liter | Standard Deviation 1.0227 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 24, n=109 | 0.221 10^9 cells/Liter | Standard Deviation 1.1556 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 28, n=84 | -0.032 10^9 cells/Liter | Standard Deviation 1.1173 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 1, n=168 | -0.001 10^9 cells/Liter | Standard Deviation 0.027 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 6, n=137 | 0.004 10^9 cells/Liter | Standard Deviation 0.0245 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 20, n=92 | 0.004 10^9 cells/Liter | Standard Deviation 0.0271 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 36, n=91 | 0.006 10^9 cells/Liter | Standard Deviation 0.0295 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 68, n=43 | 0.001 10^9 cells/Liter | Standard Deviation 0.0197 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 72, n=53 | -0.003 10^9 cells/Liter | Standard Deviation 0.0227 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 76, n=31 | -0.000 10^9 cells/Liter | Standard Deviation 0.0218 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 88, n=16 | 0.003 10^9 cells/Liter | Standard Deviation 0.0202 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 92, n=15 | 0.005 10^9 cells/Liter | Standard Deviation 0.0288 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Basophils, Mon 100, n=7 | 0.021 10^9 cells/Liter | Standard Deviation 0.0157 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 3, n=153 | -0.010 10^9 cells/Liter | Standard Deviation 0.1329 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 20, n=92 | -0.009 10^9 cells/Liter | Standard Deviation 0.0941 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Eosinophils, Mon 60, n=71 | -0.014 10^9 cells/Liter | Standard Deviation 0.1123 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 9, n=121 | -0.031 10^9 cells/Liter | Standard Deviation 0.472 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 40, n=74 | -0.028 10^9 cells/Liter | Standard Deviation 0.4699 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Lymphocytes, Mon 44, n=72 | 0.008 10^9 cells/Liter | Standard Deviation 0.4681 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 68, n=43 | 0.304 10^9 cells/Liter | Standard Deviation 1.3417 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 92, n=15 | 0.275 10^9 cells/Liter | Standard Deviation 1.2747 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 96, n=19 | 0.444 10^9 cells/Liter | Standard Deviation 1.123 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 100, n=7 | 0.156 10^9 cells/Liter | Standard Deviation 0.5022 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 104, n=1 | 0.270 10^9 cells/Liter | — |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Neutrophils, Mon 108, n=10 | 0.185 10^9 cells/Liter | Standard Deviation 0.9415 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 1, n=165 | -4.1 10^9 cells/Liter | Standard Deviation 38.59 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 2, n=15 | 5.3 10^9 cells/Liter | Standard Deviation 47.49 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 3, n=150 | -5.4 10^9 cells/Liter | Standard Deviation 40.7 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 4, n=26 | -2 10^9 cells/Liter | Standard Deviation 54.42 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 6, n=131 | -7 10^9 cells/Liter | Standard Deviation 48.59 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 8, n=42 | 6 10^9 cells/Liter | Standard Deviation 49.17 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 9, n=119 | -4.7 10^9 cells/Liter | Standard Deviation 38.65 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 16, n=94 | -0.2 10^9 cells/Liter | Standard Deviation 46.65 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 20, n=91 | -1.9 10^9 cells/Liter | Standard Deviation 44.44 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 28, n=82 | -14.4 10^9 cells/Liter | Standard Deviation 46.6 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 32, n=82 | -23.2 10^9 cells/Liter | Standard Deviation 45.64 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 36, n=87 | -24.4 10^9 cells/Liter | Standard Deviation 39.19 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 40, n=76 | -18.0 10^9 cells/Liter | Standard Deviation 40.84 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 52, n=65 | -17.5 10^9 cells/Liter | Standard Deviation 35.27 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 56, n=62 | -21.3 10^9 cells/Liter | Standard Deviation 36.88 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 60, n=68 | -22.3 10^9 cells/Liter | Standard Deviation 38.07 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 64, n=47 | -20.2 10^9 cells/Liter | Standard Deviation 47.45 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | Platelet Count, Mon 80, n=24 | -6.3 10^9 cells/Liter | Standard Deviation 43.84 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 2, n=15 | -0.53 10^9 cells/Liter | Standard Deviation 2.281 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 36, n=91 | -0.14 10^9 cells/Liter | Standard Deviation 1.233 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 40, n=78 | 0.13 10^9 cells/Liter | Standard Deviation 1.331 |
| Overall Study | Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) | WBC, Mon 52, n=68 | 0.09 10^9 cells/Liter | Standard Deviation 1.397 |
Primary
Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score
An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and \>19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 1, n=162 | -0.2 Scores on a scale | Standard Deviation 6.17 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 12, n=153 | 0.2 Scores on a scale | Standard Deviation 6.3 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 24, n=79 | -0.1 Scores on a scale | Standard Deviation 5.91 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 36, n=81 | 0.0 Scores on a scale | Standard Deviation 4.62 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 48, n=79 | 0.5 Scores on a scale | Standard Deviation 5.53 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 60, n=65 | 0.6 Scores on a scale | Standard Deviation 4.42 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 72, n=49 | 0.4 Scores on a scale | Standard Deviation 4.84 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 84, n=33 | 1.0 Scores on a scale | Standard Deviation 4.89 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 96, n=19 | -1.0 Scores on a scale | Standard Deviation 3.76 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 108, n=10 | -0.3 Scores on a scale | Standard Deviation 5.06 |
| Overall Study | Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score | AUA, Mon 3, n=151 | -0.0 Scores on a scale | Standard Deviation 5.66 |
Primary
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 1, n=152 | 6.5 Milliliter (mL) | Standard Deviation 60.92 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 3, n=146 | 5.8 Milliliter (mL) | Standard Deviation 59.69 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 12, n=144 | -2.8 Milliliter (mL) | Standard Deviation 73.95 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 24, n=75 | 11.6 Milliliter (mL) | Standard Deviation 62.06 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 36, n=84 | 13.6 Milliliter (mL) | Standard Deviation 58.45 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 48, n=77 | 8.8 Milliliter (mL) | Standard Deviation 62.28 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 60, n=65 | 20.1 Milliliter (mL) | Standard Deviation 85.81 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 72, n=48 | 17.2 Milliliter (mL) | Standard Deviation 61.82 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 84, n=31 | 40.0 Milliliter (mL) | Standard Deviation 89.38 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 96, n=19 | 8.7 Milliliter (mL) | Standard Deviation 23.32 |
| Overall Study | Change From Baseline in Post-void Residual Bladder Ultrasound Volume | PVR, Mon 108, n=10 | 17.4 Milliliter (mL) | Standard Deviation 60.89 |
Primary
Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval
A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 1, n=174 | 0.0195 Seconds (sec) | Standard Deviation 0.11576 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 3, n=159 | 0.0029 Seconds (sec) | Standard Deviation 0.12883 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 9, n=124 | 0.0103 Seconds (sec) | Standard Deviation 0.12659 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 12, n=172 | -0.0015 Seconds (sec) | Standard Deviation 0.12556 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 24, n=112 | -0.0119 Seconds (sec) | Standard Deviation 0.1206 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 36, n=92 | 0.0144 Seconds (sec) | Standard Deviation 0.12476 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 48, n=81 | 0.0145 Seconds (sec) | Standard Deviation 0.12175 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 60, n=71 | 0.0098 Seconds (sec) | Standard Deviation 0.14452 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 72, n=55 | 0.0251 Seconds (sec) | Standard Deviation 0.12713 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 84, n=36 | 0.0285 Seconds (sec) | Standard Deviation 0.15006 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 96, n=19 | -0.0237 Seconds (sec) | Standard Deviation 0.1485 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 108, n=10 | -0.0173 Seconds (sec) | Standard Deviation 0.10885 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval | RR interval, Mon 6, n=142 | -0.0007 Seconds (sec) | Standard Deviation 0.13151 |
Primary
Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)
A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 1, n=172 | 3.3 Milliseconds (msec) | Standard Deviation 18.13 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 3, n=157 | 5.8 Milliseconds (msec) | Standard Deviation 18.84 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 6, n=139 | 1.5 Milliseconds (msec) | Standard Deviation 17.29 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 9, n=121 | 2.2 Milliseconds (msec) | Standard Deviation 17.18 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 36, n=89 | 3.7 Milliseconds (msec) | Standard Deviation 20.32 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 60, n=70 | 5.1 Milliseconds (msec) | Standard Deviation 17.76 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 1, n=172 | 4.7 Milliseconds (msec) | Standard Deviation 16.12 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 3, n=157 | 6.0 Milliseconds (msec) | Standard Deviation 16.57 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 6, n=139 | 1.4 Milliseconds (msec) | Standard Deviation 15.79 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 24, n=109 | 4.7 Milliseconds (msec) | Standard Deviation 15.91 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 36, n=89 | 4.3 Milliseconds (msec) | Standard Deviation 16.58 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 48, n=80 | 5.9 Milliseconds (msec) | Standard Deviation 14.93 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 60, n=70 | 5.9 Milliseconds (msec) | Standard Deviation 13.94 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 72, n=54 | 7.2 Milliseconds (msec) | Standard Deviation 16.89 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 84, n=36 | 9.3 Milliseconds (msec) | Standard Deviation 14.2 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 108, n=10 | -5.7 Milliseconds (msec) | Standard Deviation 12.64 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 1, n=173 | -0.8 Milliseconds (msec) | Standard Deviation 13.07 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 3, n=158 | 1.0 Milliseconds (msec) | Standard Deviation 12.99 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 9, n=123 | -1.4 Milliseconds (msec) | Standard Deviation 12.44 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 24, n=110 | -3.1 Milliseconds (msec) | Standard Deviation 12.16 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 36, n=89 | -0.3 Milliseconds (msec) | Standard Deviation 11.39 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 60, n=71 | 2.5 Milliseconds (msec) | Standard Deviation 14.12 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 72, n=53 | 2.2 Milliseconds (msec) | Standard Deviation 11.71 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 1, n=174 | 0.4 Milliseconds (msec) | Standard Deviation 7.37 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 3, n=159 | -0.2 Milliseconds (msec) | Standard Deviation 7.64 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 6, n=142 | -0.2 Milliseconds (msec) | Standard Deviation 7.05 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 9, n=124 | 0.4 Milliseconds (msec) | Standard Deviation 8.04 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 12, n=171 | -0.0 Milliseconds (msec) | Standard Deviation 9.4 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 48, n=81 | 4.0 Milliseconds (msec) | Standard Deviation 7.82 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 60, n=70 | 3.9 Milliseconds (msec) | Standard Deviation 8.19 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 84, n=36 | 4.2 Milliseconds (msec) | Standard Deviation 7.94 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 96, n=19 | 3.8 Milliseconds (msec) | Standard Deviation 7.21 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 1, n=172 | 7.5 Milliseconds (msec) | Standard Deviation 22.93 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 6, n=139 | 1.4 Milliseconds (msec) | Standard Deviation 25.95 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 9, n=121 | 4.3 Milliseconds (msec) | Standard Deviation 25 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 12, n=168 | 5.1 Milliseconds (msec) | Standard Deviation 24.7 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 60, n=70 | 7.3 Milliseconds (msec) | Standard Deviation 24.74 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 96, n=19 | 5.4 Milliseconds (msec) | Standard Deviation 26.73 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 108, n=10 | -8.7 Milliseconds (msec) | Standard Deviation 14.01 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 12, n=168 | 5.7 Milliseconds (msec) | Standard Deviation 19.18 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 24, n=109 | 5.9 Milliseconds (msec) | Standard Deviation 18.52 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 48, n=80 | 5.4 Milliseconds (msec) | Standard Deviation 17.74 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 72, n=54 | 5.5 Milliseconds (msec) | Standard Deviation 15.86 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 84, n=36 | 8.1 Milliseconds (msec) | Standard Deviation 16.02 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 96, n=19 | 11.0 Milliseconds (msec) | Standard Deviation 15.95 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcB, Mon 108, n=10 | -3.7 Milliseconds (msec) | Standard Deviation 17.25 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 9, n=121 | 2.9 Milliseconds (msec) | Standard Deviation 15.57 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 12, n=168 | 5.5 Milliseconds (msec) | Standard Deviation 16.51 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QTcF, Mon 96, n=19 | 8.9 Milliseconds (msec) | Standard Deviation 14.83 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 6, n=139 | 0.0 Milliseconds (msec) | Standard Deviation 12.69 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 12, n=168 | -1.0 Milliseconds (msec) | Standard Deviation 12.61 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 48, n=80 | 0.3 Milliseconds (msec) | Standard Deviation 16.32 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 84, n=36 | 4.3 Milliseconds (msec) | Standard Deviation 9.34 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 96, n=19 | -2.4 Milliseconds (msec) | Standard Deviation 13 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | PR interval, Mon 108, n=10 | 0.0 Milliseconds (msec) | Standard Deviation 15.5 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 24, n=112 | 0.7 Milliseconds (msec) | Standard Deviation 8.56 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 36, n=90 | 1.6 Milliseconds (msec) | Standard Deviation 7.31 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 72, n=55 | 6.2 Milliseconds (msec) | Standard Deviation 9.15 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | QRS duration, Mon 108, n=10 | 3.7 Milliseconds (msec) | Standard Deviation 9.4 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 3, n=157 | 6.4 Milliseconds (msec) | Standard Deviation 25.31 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 24, n=109 | 2.8 Milliseconds (msec) | Standard Deviation 23.97 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 36, n=89 | 5.5 Milliseconds (msec) | Standard Deviation 22.57 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 48, n=80 | 7.2 Milliseconds (msec) | Standard Deviation 22.42 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 72, n=54 | 11.0 Milliseconds (msec) | Standard Deviation 28.33 |
| Overall Study | Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) | uQT, Mon 84, n=36 | 12.5 Milliseconds (msec) | Standard Deviation 26.56 |
Primary
Change From Baseline in Urine Power of Hydrogen (pH)
Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 1, n=166 | -0.13 pH units | Standard Deviation 0.721 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 3, n=157 | -0.18 pH units | Standard Deviation 0.791 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 6, n=137 | -0.13 pH units | Standard Deviation 0.767 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 9, n=121 | -0.17 pH units | Standard Deviation 0.771 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 12, n=170 | -0.11 pH units | Standard Deviation 0.793 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 16, n=100 | -0.05 pH units | Standard Deviation 0.764 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 20, n=97 | -0.20 pH units | Standard Deviation 0.886 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 24, n=109 | -0.09 pH units | Standard Deviation 0.713 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 28, n=86 | -0.01 pH units | Standard Deviation 0.893 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 32, n=82 | -0.10 pH units | Standard Deviation 0.768 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 36, n=89 | 0.12 pH units | Standard Deviation 0.83 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 40, n=76 | 0.09 pH units | Standard Deviation 0.842 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 44, n=72 | 0.12 pH units | Standard Deviation 0.767 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 48, n=80 | 0.19 pH units | Standard Deviation 0.828 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 52, n=67 | 0.17 pH units | Standard Deviation 0.851 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 56, n=62 | 0.06 pH units | Standard Deviation 0.769 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 60, n=68 | 0.24 pH units | Standard Deviation 0.896 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 64, n=49 | 0.19 pH units | Standard Deviation 0.934 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 68, n=42 | 0.12 pH units | Standard Deviation 0.825 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 84, n=36 | 0.00 pH units | Standard Deviation 0.862 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 88, n=17 | 0.21 pH units | Standard Deviation 1.032 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 92, n=16 | 0.28 pH units | Standard Deviation 1.224 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 96, n=19 | 0.26 pH units | Standard Deviation 0.888 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 100, n=7 | 0.14 pH units | Standard Deviation 1.18 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 104, n=1 | 0.50 pH units | — |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 108, n=10 | 0.65 pH units | Standard Deviation 0.747 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 72, n=53 | 0.16 pH units | Standard Deviation 0.842 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 76, n=31 | 0.13 pH units | Standard Deviation 1 |
| Overall Study | Change From Baseline in Urine Power of Hydrogen (pH) | UpH, Mon 80, n=23 | 0.24 pH units | Standard Deviation 0.89 |
Primary
Change From Baseline in Urine Specific Gravity
Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 24, n=109 | -0.0012 Dimensionless unit | Standard Deviation 0.00985 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 28, n=86 | -0.0003 Dimensionless unit | Standard Deviation 0.01032 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 32, n=82 | -0.0006 Dimensionless unit | Standard Deviation 0.00935 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 36, n=89 | -0.0024 Dimensionless unit | Standard Deviation 0.0086 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 68, n=42 | -0.0022 Dimensionless unit | Standard Deviation 0.00822 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 72, n=53 | -0.0015 Dimensionless unit | Standard Deviation 0.01006 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 76, n=31 | -0.0024 Dimensionless unit | Standard Deviation 0.00822 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 80, n=23 | -0.0021 Dimensionless unit | Standard Deviation 0.00867 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 84, n=35 | -0.0028 Dimensionless unit | Standard Deviation 0.00862 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 88, n=17 | -0.0055 Dimensionless unit | Standard Deviation 0.00833 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 92, n=16 | -0.0030 Dimensionless unit | Standard Deviation 0.01116 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 96, n=19 | -0.0039 Dimensionless unit | Standard Deviation 0.00956 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 100, n=7 | -0.0013 Dimensionless unit | Standard Deviation 0.00886 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 104, n=1 | -0.0150 Dimensionless unit | — |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 108, n=10 | -0.0014 Dimensionless unit | Standard Deviation 0.01032 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 1, n=166 | -0.0018 Dimensionless unit | Standard Deviation 0.00848 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 3, n=157 | -0.0016 Dimensionless unit | Standard Deviation 0.00852 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 6, n=137 | 0.0002 Dimensionless unit | Standard Deviation 0.0093 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 9, n=121 | 0.0002 Dimensionless unit | Standard Deviation 0.00933 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 12, n=170 | -0.0000 Dimensionless unit | Standard Deviation 0.00937 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 16, n=100 | 0.0006 Dimensionless unit | Standard Deviation 0.0096 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 20, n=97 | 0.0008 Dimensionless unit | Standard Deviation 0.00964 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 40, n=76 | -0.0005 Dimensionless unit | Standard Deviation 0.00865 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 44, n=72 | -0.0007 Dimensionless unit | Standard Deviation 0.00867 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 48, n=80 | -0.0015 Dimensionless unit | Standard Deviation 0.00941 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 52, n=67 | 0.0002 Dimensionless unit | Standard Deviation 0.00972 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 56, n=62 | -0.0003 Dimensionless unit | Standard Deviation 0.00899 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 60, n=68 | -0.0023 Dimensionless unit | Standard Deviation 0.00893 |
| Overall Study | Change From Baseline in Urine Specific Gravity | USG, Mon 64, n=49 | -0.0022 Dimensionless unit | Standard Deviation 0.00938 |
Primary
Change From Baseline in Weight
Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time frame: Baseline and Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Weight | Weight, Mon 1, n=172 | 1.94 Kilograms | Standard Deviation 3.691 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 3, n=159 | 1.85 Kilograms | Standard Deviation 6.455 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 6, n=143 | 1.68 Kilograms | Standard Deviation 5.315 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 9, n=123 | 1.57 Kilograms | Standard Deviation 6.149 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 12, n=171 | 1.31 Kilograms | Standard Deviation 6.961 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 16, n=104 | 2.17 Kilograms | Standard Deviation 8.799 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 28, n=88 | 0.35 Kilograms | Standard Deviation 8.859 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 56, n=62 | 1.28 Kilograms | Standard Deviation 8.998 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 68, n=44 | 2.77 Kilograms | Standard Deviation 9.79 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 72, n=57 | 0.85 Kilograms | Standard Deviation 10.701 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 76, n=31 | 3.30 Kilograms | Standard Deviation 8.26 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 80, n=24 | 1.48 Kilograms | Standard Deviation 7.899 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 84, n=36 | 2.47 Kilograms | Standard Deviation 10.022 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 88, n=17 | 1.45 Kilograms | Standard Deviation 9.036 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 92, n=16 | 1.64 Kilograms | Standard Deviation 7.571 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 96, n=19 | 0.48 Kilograms | Standard Deviation 9.38 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 100, n=7 | 4.31 Kilograms | Standard Deviation 7.006 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 104, n=1 | 2.10 Kilograms | — |
| Overall Study | Change From Baseline in Weight | Weight, Mon 20, n=101 | 1.62 Kilograms | Standard Deviation 7.786 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 24, n=111 | 1.21 Kilograms | Standard Deviation 8.178 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 32, n=85 | 0.07 Kilograms | Standard Deviation 9.084 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 36, n=92 | 0.61 Kilograms | Standard Deviation 8.066 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 40, n=78 | 0.84 Kilograms | Standard Deviation 9.106 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 44, n=76 | 0.88 Kilograms | Standard Deviation 8.137 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 48, n=82 | 0.73 Kilograms | Standard Deviation 9.097 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 52, n=68 | 1.10 Kilograms | Standard Deviation 9.401 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 60, n=69 | 0.94 Kilograms | Standard Deviation 9.335 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 64, n=49 | 2.13 Kilograms | Standard Deviation 10.004 |
| Overall Study | Change From Baseline in Weight | Weight, Mon 108, n=10 | 3.18 Kilograms | Standard Deviation 5.743 |
Primary
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as events. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 0,n= 181 | 0.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 6,n= 179 | 1.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 12,n= 177 | 2.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 13,n= 176 | 2.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 18,n= 175 | 3.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 21,n= 173 | 4.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 26,n= 172 | 5.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 27,n= 170 | 6.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 28,n= 169 | 6.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 29,n= 168 | 7.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 32,n= 166 | 8.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 39,n= 163 | 9.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 50,n= 162 | 10.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 52,n= 161 | 11.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 55,n= 160 | 11.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 67,n= 158 | 12.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 85,n= 157 | 13.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 89,n= 155 | 14.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 91,n= 153 | 15.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 93,n= 152 | 16.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 109,n= 150 | 17.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 118,n= 149 | 17.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 119,n= 148 | 18.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 124,n= 147 | 18.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 134,n= 146 | 19.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 135,n= 145 | 19.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 140,n= 144 | 20.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 144,n= 143 | 21.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 166,n= 142 | 21.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 167,n= 141 | 22.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 175,n= 140 | 22.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 180,n= 138 | 23.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 181,n= 137 | 24.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 182,n= 135 | 25.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 188,n= 133 | 26.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 207,n= 132 | 27.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 210,n= 131 | 27.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 216,n= 128 | 29.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 224,n= 127 | 29.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 231,n= 126 | 30.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 237,n= 125 | 30.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 303,n= 117 | 35.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 338,n= 113 | 37.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 358,n= 112 | 38.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 361,n= 111 | 38.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 362,n= 110 | 39.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 372,n= 109 | 39.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 377,n= 108 | 40.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 392,n= 107 | 40.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 413,n= 105 | 42.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 477,n= 104 | 42.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 479,n= 103 | 43.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 483,n= 102 | 43.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 593,n= 99 | 45.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 602,n= 98 | 45.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 603,n= 97 | 46.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 606,n= 96 | 47.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 609,n= 95 | 47.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 660,n= 94 | 48.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 685,n= 93 | 48.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 722,n= 92 | 49.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 783,n= 91 | 49.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 848,n= 87 | 51.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1084,n= 82 | 54.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1090,n= 81 | 55.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1196,n= 78 | 56.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1322,n= 75 | 58.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1326,n= 74 | 59.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1407,n= 71 | 60.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1429,n= 70 | 61.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1520,n= 69 | 61.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1561,n= 68 | 62.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1563,n= 67 | 63.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1619,n= 66 | 63.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1645,n= 65 | 63.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1655,n= 64 | 63.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1656,n= 63 | 63.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1673,n= 62 | 63.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1885,n= 53 | 67.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2008,n= 46 | 68.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2038,n= 45 | 68.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2044,n= 44 | 69.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2051,n= 43 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2073,n= 42 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2157,n= 38 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2161,n= 37 | 70.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2248,n= 32 | 72.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2274,n= 31 | 73.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2278,n= 30 | 73.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2282,n= 28 | 74.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2290,n= 27 | 75.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2294,n= 26 | 76.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2297,n= 25 | 77.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2301,n= 24 | 78.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2337,n= 23 | 79.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2523,n= 21 | 81.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2535,n= 18 | 83.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2795,n= 11 | 90.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2833,n= 10 | 91.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3023,n= 4 | 96.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3092,n= 2 | 98.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2,n= 180 | 0.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 8,n= 178 | 1.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 20,n= 174 | 3.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 30,n= 167 | 7.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 33,n= 164 | 9.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 96,n= 151 | 16.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 179,n= 139 | 23.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 185,n= 134 | 26.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 211,n= 130 | 28.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 213,n= 129 | 28.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 240,n= 124 | 31.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 253,n= 123 | 32.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 271,n= 122 | 32.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 278,n= 121 | 33.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 280,n= 120 | 33.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 281,n= 119 | 34.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 282,n= 118 | 34.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 315,n= 116 | 35.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 336,n= 114 | 37.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 407,n= 106 | 41.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 489,n= 101 | 44.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 535,n= 100 | 44.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 821,n= 90 | 50.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 843,n= 88 | 51.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 881,n= 86 | 52.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 959,n= 85 | 53.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1076,n= 84 | 53.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1080,n= 83 | 54.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1119,n= 80 | 55.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1146,n= 79 | 56.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1210,n= 77 | 57.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1225,n= 76 | 58.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1338,n= 73 | 59.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1339,n= 72 | 60.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1676,n= 61 | 64.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1686,n= 60 | 64.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1737,n= 59 | 64.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1780,n= 58 | 64.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1800,n= 57 | 65.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1811,n= 56 | 66.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1813,n= 55 | 66.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1862,n= 54 | 66.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1911,n= 52 | 67.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1926,n= 51 | 67.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1933,n= 50 | 67.2 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1952,n= 49 | 67.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1989,n= 48 | 67.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 1994,n= 47 | 68.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2109,n= 41 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2111,n= 40 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2139,n= 39 | 69.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2164,n= 36 | 71.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2170,n= 35 | 72.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2228,n= 34 | 72.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2234,n= 33 | 72.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2393,n= 22 | 80.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2527,n= 20 | 82.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2528,n= 19 | 83.0 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2646,n= 16 | 85.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2702,n= 15 | 86.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2735,n= 14 | 87.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2768,n= 13 | 88.4 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2792,n= 12 | 89.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2848,n= 9 | 91.9 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2871,n= 8 | 92.8 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 2886,n= 7 | 93.7 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3001,n= 6 | 94.6 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3004,n= 5 | 95.5 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3091,n= 3 | 97.3 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3101,n= 1 | 99.1 Percentage Probability of d/c |
| Overall Study | Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug | Day 3186,n= 0 | 100.0 Percentage Probability of d/c |
Primary
Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa
An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly 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: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Any abnormal dermatologic discoloration | 23 Participants |
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of skin | 15 Participants |
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of lips | 16 Participants |
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of nails | 21 Participants |
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of mucosa | 17 Participants |
| Overall Study | Number 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 | 22 Participants |
| Overall Study | Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa | Abnormal discoloration of non su-exposed tissue | 18 Participants |
Primary
Number of Participants With Abnormal Results in Physical Examination
A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category
Time frame: Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Baseline, n=181 | 59 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 12, n=169 | 49 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 24, n=113 | 34 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 36, n=92 | 27 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 48, n=82 | 25 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 60, 69 | 32 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 72, n=56 | 31 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 84, n=36 | 25 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 96, n=19 | 10 Participants |
| Overall Study | Number of Participants With Abnormal Results in Physical Examination | Mon 108, n=10 | 5 Participants |
Primary
Number of Participants With Abnormal Results of Neurological Examination
Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Month 108
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Baseline, n= 173, AbNCS | 60 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Baseline, n= 173, AbCS | 11 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 1, n= 173, AbNCS | 49 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 1, n= 173, AbCS | 17 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 3, n= 159, AbNCS | 42 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 3, n= 159, AbCS | 9 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 6, n= 141, AbNCS | 35 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 6, n= 141, AbCS | 8 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 9, n= 125, AbNCS | 32 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 9, n= 125, AbCS | 9 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 12, n= 171, AbNCS | 56 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 12, n= 171, AbCS | 13 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 16, n= 104, AbNCS | 23 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 16, n= 104, AbCS | 10 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 20, n= 98, AbNCS | 28 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 20, n= 98, AbCS | 6 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 24, n= 113, AbNCS | 35 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 24, n= 113, AbCS | 6 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 28, n= 87, AbNCS | 23 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 28, n= 87, AbCS | 6 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 32, n= 86, AbNCS | 19 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 32, n= 86, AbCS | 5 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 36, n= 92, AbNCS | 28 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 36, n= 92, AbCS | 6 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 40, n= 78, AbNCS | 22 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 40, n= 78, AbCS | 8 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 44, n= 76, AbNCS | 25 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 44, n= 76, AbCS | 3 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 48, n= 82, AbNCS | 25 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 48, n= 82, AbCS | 6 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 52, n= 67, AbNCS | 19 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 52, n= 67, AbCS | 4 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 56, n= 63, AbNCS | 19 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 56, n= 63, AbCS | 4 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 88, n= 17, AbNCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 88, n= 17, AbCS | 1 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 92, n= 16, AbNCS | 2 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 92, n= 16, AbCS | 1 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 96, n= 19, AbNCS | 4 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 96, n= 19, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 100, n= 7, AbNCS | 2 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 60, n= 68, AbNCS | 27 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 60, n= 68, AbCS | 3 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 64, n= 50, AbNCS | 21 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 64, n= 50, AbCS | 1 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 68, n= 44, AbNCS | 15 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 68, n= 44, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 72, n= 56, AbNCS | 20 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 72, n= 56, AbCS | 4 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 76, n= 31, AbNCS | 11 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 76, n= 31, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 80, n= 24, AbNCS | 7 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 80, n= 24, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 84, n= 36, AbNCS | 14 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 84, n= 36, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 100, n= 7, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 104, n= 1, AbNCS | 1 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 104, n= 1, AbCS | 0 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 108, n= 10, AbNCS | 2 Participants |
| Overall Study | Number of Participants With Abnormal Results of Neurological Examination | Mon 108, n= 10, AbCS | 0 Participants |
Primary
Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | 2 Participants |
Primary
Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination
Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination | 0 Participants |
Primary
Number of Participants With Pigmentation of Non-retinal Ocular Tissue
The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With Pigmentation of Non-retinal Ocular Tissue | 11 Participants |
Primary
Number of Participants With Pigmentation of Retinal Ocular Tissue
The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With Pigmentation of Retinal Ocular Tissue | 14 Participants |
Primary
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 and non-retinal ocular pigmentary abnormality.
Time frame: 2 years and 9 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 (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Retinal pigmentary abnormality | 1 Participants |
| Overall Study | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Pigmentary abnormality of macula | 1 Participants |
| Overall Study | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Pigmentary abnormality of peripheral retina | 3 Participants |
| Overall Study | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine | Non-retinal ocular pigmentary abnormality | 4 Participants |
Primary
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: 2 years 9 months
Population: All SFUCP Subjects Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine | 1 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug
Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug | 52 Participants. |
Primary
Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
An AE is 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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population included all participants who took at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) | Any Treatment-emergent SAE | 48 Participants |
| Overall Study | Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) | Any Treatment-emergent AE | 173 Participants |
Primary
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: 2 years 9 months
Population: All SFUCP Subjects Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Study | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Pigmentary Abnormality of Peripheral Retina, n=3 | 317.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Non-Retinal Ocular Pigmentary Abnormality, n=4 | 180.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Retinal Pigmentary Abnormality, n=1 | 317.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation | Pigmentary Abnormality of Macula, n=1 | 163.0 Days |
Primary
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: 2 years 9 months
Population: All SFUCP Subjects Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Study | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | All, n=1 | 439.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Lips, n=4 | 284.5 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Nails,n=7 | 377.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Mucosa, n=3 | 468.0 Days |
| Overall Study | Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration | Skin, n=5 | 347.0 Days |
Secondary
Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire
The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 3, n= 133 | -2 Scores on a scale | Standard Deviation 12.992 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 6, n= 130 | -2.95 Scores on a scale | Standard Deviation 12.729 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 9, n= 114 | -1.65 Scores on a scale | Standard Deviation 13.074 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 12, n= 156 | -2.77 Scores on a scale | Standard Deviation 13.616 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 24, n= 102 | -3.13 Scores on a scale | Standard Deviation 13.602 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 48, n= 74 | -1.05 Scores on a scale | Standard Deviation 12.605 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 60, n= 60 | -0.41 Scores on a scale | Standard Deviation 13.309 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 36, n= 81 | -2.43 Scores on a scale | Standard Deviation 13.925 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 72, n= 49 | -0.35 Scores on a scale | Standard Deviation 14.382 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 84, n= 28 | 0.19 Scores on a scale | Standard Deviation 14.699 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 96, n= 18 | -0.25 Scores on a scale | Standard Deviation 17.986 |
| Overall Study | Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire | Mon 108, n= 11 | 1.55 Scores on a scale | Standard Deviation 18.768 |
Secondary
Number of Participants Who Were Seizure Free for Any 12 Continuous Months
Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as \>= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants Who Were Seizure Free for Any 12 Continuous Months | 14 Participants |
Secondary
Number of Participants Who Were Seizure Free for Any 6 Continuous Months
Number of seizure free days 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. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as \>= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Participants Who Were Seizure Free for Any 6 Continuous Months | 20 Participants |
Secondary
Number of Responders
A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Responders | 98 Participants |
Secondary
Percentage Change From Baseline in the 28-day Partial Seizure
Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Percentage Change From Baseline in the 28-day Partial Seizure | -34.2 Percent change | Standard Deviation 68.7 |
Secondary
Percentage of Seizure-free Days
Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days
Time frame: Assessed up to a maximum of 9 years
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study | Percentage of Seizure-free Days | 75.7 Percentage of days | Standard Deviation 25.92 |