Trial Outcomes & Findings for Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial (NCT NCT00310375)
NCT ID: NCT00310375
Last Updated: 2020-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
181 participants
Primary outcome timeframe
Assessed up to a maximum of 9 years
Results posted on
2020-07-31
Participant Flow
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mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.
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.
Participant milestones
| Measure |
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as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product.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.
|
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as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product.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.
|
Safety Follow-up Continuation Phase (SFUCP)
Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
|
|---|---|---|---|
|
Primary Reporting Phase
STARTED
|
102
|
79
|
0
|
|
Primary Reporting Phase
COMPLETED
|
11
|
11
|
0
|
|
Primary Reporting Phase
NOT COMPLETED
|
91
|
68
|
0
|
|
Safety Follow-up Continuation Phase
STARTED
|
0
|
0
|
19
|
|
Safety Follow-up Continuation Phase
COMPLETED
|
0
|
0
|
18
|
|
Safety Follow-up Continuation Phase
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Safety Follow-up Continuation Phase (SFUCP)
Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
|
|---|---|---|---|
|
Primary Reporting Phase
Adverse Event
|
28
|
22
|
0
|
|
Primary Reporting Phase
Lack of Efficacy
|
24
|
19
|
0
|
|
Primary Reporting Phase
Pregnancy
|
2
|
2
|
0
|
|
Primary Reporting Phase
Withdrawal by Subject
|
10
|
7
|
0
|
|
Primary Reporting Phase
Protocol Violation
|
8
|
5
|
0
|
|
Primary Reporting Phase
Change in Par medical condition
|
2
|
0
|
0
|
|
Primary Reporting Phase
Transaminase >5 upper limit of normal
|
2
|
1
|
0
|
|
Primary Reporting Phase
Physician Decision
|
5
|
3
|
0
|
|
Primary Reporting Phase
Request of the sponsor
|
2
|
2
|
0
|
|
Primary Reporting Phase
Failed to return
|
1
|
3
|
0
|
|
Primary Reporting Phase
Participant request unrelated to study
|
1
|
2
|
0
|
|
Primary Reporting Phase
Going for temporal lobectomy
|
1
|
0
|
0
|
|
Primary Reporting Phase
Missed study drug >5 days
|
1
|
0
|
0
|
|
Primary Reporting Phase
Site closure
|
3
|
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
Request of Ethics Committee
|
0
|
1
|
0
|
|
Safety Follow-up Continuation Phase
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Baseline characteristics by cohort
| Measure |
Placebo in Parent Study
n=102 Participants
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.
|
Retigabine in Parent Study
n=79 Participants
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.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 Years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
37.1 Years
STANDARD_DEVIATION 12.20 • n=7 Participants
|
37.6 Years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
54 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American (black)
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Number of Participants with Vagal nerve stimulator (VNS) use
No
|
89 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Number of Participants with Vagal nerve stimulator (VNS) use
Yes
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Number of background AEDs
AED=1
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of background AEDs
AED=2
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Number of background AEDs
AED=3
|
43 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Mean Duration of Partial seizures
|
24.1 Years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
23.7 Years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
23.9 Years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
|
Mean Duration of Generalized Seizure
|
18.6 Years
STANDARD_DEVIATION 12.45 • n=5 Participants
|
25.8 Years
STANDARD_DEVIATION 13.25 • n=7 Participants
|
21.5 Years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Not Assessed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
No Seizures
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Very Mild Severity
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Mild Severity
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Moderate Severity
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Marked Severity
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Very Severe
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Clinical Global Impression (CGI) at Baseline
Among the Most Extremely Severe
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population included all participants who took at least 1 dose of study medication
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
Any Treatment-emergent SAE
|
48 Participants
|
|
Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
Any Treatment-emergent AE
|
173 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug
|
52 Participants.
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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).
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 0,n= 181
|
0.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2,n= 180
|
0.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 6,n= 179
|
1.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 8,n= 178
|
1.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 12,n= 177
|
2.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 13,n= 176
|
2.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 18,n= 175
|
3.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 20,n= 174
|
3.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 21,n= 173
|
4.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 26,n= 172
|
5.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 27,n= 170
|
6.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 28,n= 169
|
6.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 29,n= 168
|
7.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 30,n= 167
|
7.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 32,n= 166
|
8.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 33,n= 164
|
9.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 39,n= 163
|
9.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 50,n= 162
|
10.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 52,n= 161
|
11.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 55,n= 160
|
11.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 67,n= 158
|
12.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 85,n= 157
|
13.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 89,n= 155
|
14.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 91,n= 153
|
15.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 93,n= 152
|
16.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 96,n= 151
|
16.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 109,n= 150
|
17.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 118,n= 149
|
17.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 119,n= 148
|
18.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 124,n= 147
|
18.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 134,n= 146
|
19.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 135,n= 145
|
19.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 140,n= 144
|
20.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 144,n= 143
|
21.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 166,n= 142
|
21.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 167,n= 141
|
22.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 175,n= 140
|
22.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 179,n= 139
|
23.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 180,n= 138
|
23.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 181,n= 137
|
24.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 182,n= 135
|
25.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 185,n= 134
|
26.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 188,n= 133
|
26.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 207,n= 132
|
27.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 210,n= 131
|
27.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 211,n= 130
|
28.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 213,n= 129
|
28.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 216,n= 128
|
29.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 224,n= 127
|
29.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 231,n= 126
|
30.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 237,n= 125
|
30.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 240,n= 124
|
31.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 253,n= 123
|
32.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 271,n= 122
|
32.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 278,n= 121
|
33.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 280,n= 120
|
33.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 281,n= 119
|
34.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 282,n= 118
|
34.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 303,n= 117
|
35.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 315,n= 116
|
35.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 336,n= 114
|
37.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 338,n= 113
|
37.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 358,n= 112
|
38.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 361,n= 111
|
38.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 362,n= 110
|
39.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 372,n= 109
|
39.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 377,n= 108
|
40.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 392,n= 107
|
40.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 407,n= 106
|
41.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 413,n= 105
|
42.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 477,n= 104
|
42.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 479,n= 103
|
43.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 483,n= 102
|
43.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 489,n= 101
|
44.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 535,n= 100
|
44.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 593,n= 99
|
45.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 602,n= 98
|
45.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 603,n= 97
|
46.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 606,n= 96
|
47.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 609,n= 95
|
47.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 660,n= 94
|
48.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 685,n= 93
|
48.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 722,n= 92
|
49.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 783,n= 91
|
49.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 821,n= 90
|
50.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 843,n= 88
|
51.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 848,n= 87
|
51.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 881,n= 86
|
52.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 959,n= 85
|
53.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1076,n= 84
|
53.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1080,n= 83
|
54.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1084,n= 82
|
54.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1090,n= 81
|
55.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1119,n= 80
|
55.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1146,n= 79
|
56.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1196,n= 78
|
56.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1210,n= 77
|
57.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1225,n= 76
|
58.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1322,n= 75
|
58.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1326,n= 74
|
59.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1338,n= 73
|
59.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1339,n= 72
|
60.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1407,n= 71
|
60.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1429,n= 70
|
61.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1520,n= 69
|
61.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1561,n= 68
|
62.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1563,n= 67
|
63.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1619,n= 66
|
63.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1645,n= 65
|
63.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1655,n= 64
|
63.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1656,n= 63
|
63.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1673,n= 62
|
63.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1676,n= 61
|
64.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1686,n= 60
|
64.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1737,n= 59
|
64.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1780,n= 58
|
64.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1800,n= 57
|
65.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1811,n= 56
|
66.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1813,n= 55
|
66.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1862,n= 54
|
66.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1885,n= 53
|
67.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1911,n= 52
|
67.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1926,n= 51
|
67.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1933,n= 50
|
67.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1952,n= 49
|
67.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1989,n= 48
|
67.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 1994,n= 47
|
68.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2008,n= 46
|
68.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2038,n= 45
|
68.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2044,n= 44
|
69.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2051,n= 43
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2073,n= 42
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2109,n= 41
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2111,n= 40
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2139,n= 39
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2157,n= 38
|
69.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2161,n= 37
|
70.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2164,n= 36
|
71.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2170,n= 35
|
72.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2228,n= 34
|
72.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2234,n= 33
|
72.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2248,n= 32
|
72.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2274,n= 31
|
73.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2278,n= 30
|
73.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2282,n= 28
|
74.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2290,n= 27
|
75.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2294,n= 26
|
76.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2297,n= 25
|
77.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2301,n= 24
|
78.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2337,n= 23
|
79.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2393,n= 22
|
80.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2523,n= 21
|
81.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2527,n= 20
|
82.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2528,n= 19
|
83.0 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2535,n= 18
|
83.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2646,n= 16
|
85.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2702,n= 15
|
86.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2735,n= 14
|
87.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2768,n= 13
|
88.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2792,n= 12
|
89.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2795,n= 11
|
90.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2833,n= 10
|
91.1 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2848,n= 9
|
91.9 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2871,n= 8
|
92.8 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 2886,n= 7
|
93.7 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3001,n= 6
|
94.6 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3004,n= 5
|
95.5 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3023,n= 4
|
96.4 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3091,n= 3
|
97.3 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3092,n= 2
|
98.2 Percentage Probability of d/c
|
|
Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Day 3101,n= 1
|
99.1 Percentage Probability of d/c
|
|
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 outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Blood Pressure
Su DBP Mon 1, n=173
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 9.74
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 3, n=159
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 9.73
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 6, n=143
|
-2.9 Millimeter of mercury (mmHg)
Standard Deviation 10.61
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 9, n=125
|
-2.6 Millimeter of mercury (mmHg)
Standard Deviation 10.72
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 12, n=173
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 11.08
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 16, n=104
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 11.69
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 20, n=100
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 13.12
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 24, n=112
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 11.24
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 28, n=88
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 12.75
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 32, n=85
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 11.18
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 36, n=92
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 10.81
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 40, n=78
|
-2.5 Millimeter of mercury (mmHg)
Standard Deviation 11.62
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 44, n=76
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 11.75
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 48, n=82
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 11.76
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 52, n=68
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 9.74
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 56, n=63
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 11.37
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 60, n=70
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 11.67
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 64, n=50
|
-1.7 Millimeter of mercury (mmHg)
Standard Deviation 11.34
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 68, n=45
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 11.24
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 72, n=57
|
0.2 Millimeter of mercury (mmHg)
Standard Deviation 11.02
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 76, n=31
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 9.01
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 80, n=24
|
-1 Millimeter of mercury (mmHg)
Standard Deviation 7.13
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 84, n=36
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 11.04
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 88, n=17
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 6.94
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 92, n=16
|
-2.8 Millimeter of mercury (mmHg)
Standard Deviation 8.49
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 96, n=19
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 8.3
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 100, n=7
|
-6.3 Millimeter of mercury (mmHg)
Standard Deviation 3.25
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 104, n=1
|
-20.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Blood Pressure
Su DBP Mon 108, n=10
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 7.27
|
|
Change From Baseline in Blood Pressure
St DBP Mon 1, n=173
|
-0.5 Millimeter of mercury (mmHg)
Standard Deviation 9.97
|
|
Change From Baseline in Blood Pressure
St DBP Mon 3, n=159
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 11.68
|
|
Change From Baseline in Blood Pressure
St DBP Mon 6, n=143
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 11.47
|
|
Change From Baseline in Blood Pressure
St DBP Mon 9, n=125
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 10.17
|
|
Change From Baseline in Blood Pressure
St DBP Mon 12, n=170
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 11.18
|
|
Change From Baseline in Blood Pressure
St DBP Mon 16, n=104
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 11.14
|
|
Change From Baseline in Blood Pressure
St DBP Mon 20, n=100
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 12.02
|
|
Change From Baseline in Blood Pressure
St DBP Mon 24, n=110
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 11.78
|
|
Change From Baseline in Blood Pressure
St DBP Mon 28, n=87
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 12.83
|
|
Change From Baseline in Blood Pressure
St DBP Mon 32, n=84
|
0.9 Millimeter of mercury (mmHg)
Standard Deviation 11.95
|
|
Change From Baseline in Blood Pressure
St DBP Mon 36, n=91
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 10.78
|
|
Change From Baseline in Blood Pressure
St DBP Mon 40, n=77
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 11.09
|
|
Change From Baseline in Blood Pressure
St DBP Mon 44, n=75
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 11.67
|
|
Change From Baseline in Blood Pressure
St DBP Mon 48, n=81
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 11.74
|
|
Change From Baseline in Blood Pressure
St DBP Mon 52, n=67
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 11.49
|
|
Change From Baseline in Blood Pressure
St DBP Mon 56, n=62
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 11.2
|
|
Change From Baseline in Blood Pressure
St DBP Mon 60, n=69
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 14.12
|
|
Change From Baseline in Blood Pressure
St DBP Mon 64, n=49
|
-2.1 Millimeter of mercury (mmHg)
Standard Deviation 11.94
|
|
Change From Baseline in Blood Pressure
St DBP Mon 68, n=45
|
-2.9 Millimeter of mercury (mmHg)
Standard Deviation 11.91
|
|
Change From Baseline in Blood Pressure
St DBP Mon 72, n=56
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 11.13
|
|
Change From Baseline in Blood Pressure
St DBP Mon 76, n=30
|
-2.4 Millimeter of mercury (mmHg)
Standard Deviation 13.08
|
|
Change From Baseline in Blood Pressure
St DBP Mon 80, n=23
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 10.86
|
|
Change From Baseline in Blood Pressure
St DBP Mon 84, n=34
|
-0.6 Millimeter of mercury (mmHg)
Standard Deviation 12.17
|
|
Change From Baseline in Blood Pressure
St DBP Mon 88, n=17
|
0.6 Millimeter of mercury (mmHg)
Standard Deviation 8.99
|
|
Change From Baseline in Blood Pressure
St DBP Mon 92, n=16
|
-3.1 Millimeter of mercury (mmHg)
Standard Deviation 9.84
|
|
Change From Baseline in Blood Pressure
St DBP Mon 96, n=19
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 8.81
|
|
Change From Baseline in Blood Pressure
St DBP Mon 100, n=7
|
-4.9 Millimeter of mercury (mmHg)
Standard Deviation 4.41
|
|
Change From Baseline in Blood Pressure
St DBP Mon 104, n=1
|
-20.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Blood Pressure
St DBP Mon 108, n=10
|
-4.5 Millimeter of mercury (mmHg)
Standard Deviation 5.46
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 1, n=173
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 14.70
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 3, n=159
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 12.96
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 6, n=143
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 14.78
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 9, n=125
|
-0.4 Millimeter of mercury (mmHg)
Standard Deviation 14.14
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 12, n=173
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 15.70
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 16, n=104
|
-2.2 Millimeter of mercury (mmHg)
Standard Deviation 15.08
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 20, n=100
|
-0.7 Millimeter of mercury (mmHg)
Standard Deviation 15.62
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 24, n=112
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 16.11
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 28, n=88
|
-0.1 Millimeter of mercury (mmHg)
Standard Deviation 16.06
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 32, n=85
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 16.57
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 36, n=92
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 15.78
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 40, n=78
|
-0.8 Millimeter of mercury (mmHg)
Standard Deviation 15.08
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 44, n=76
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 16.62
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 48, n=82
|
2.6 Millimeter of mercury (mmHg)
Standard Deviation 15.99
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 52, n=68
|
3.3 Millimeter of mercury (mmHg)
Standard Deviation 15.32
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 56, n=63
|
1.3 Millimeter of mercury (mmHg)
Standard Deviation 15.30
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 60, n=70
|
0.7 Millimeter of mercury (mmHg)
Standard Deviation 13.57
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 64, n=50
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 18.76
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 68, n=45
|
-0.2 Millimeter of mercury (mmHg)
Standard Deviation 18.29
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 72, n=57
|
0.8 Millimeter of mercury (mmHg)
Standard Deviation 17.21
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 76, n=31
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 17.42
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 80, n=24
|
-2.6 Millimeter of mercury (mmHg)
Standard Deviation 12.80
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 84, n=36
|
-3.0 Millimeter of mercury (mmHg)
Standard Deviation 18.16
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 88, n=17
|
0.6 Millimeter of mercury (mmHg)
Standard Deviation 12.07
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 92, n=16
|
-0.9 Millimeter of mercury (mmHg)
Standard Deviation 17.07
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 96, n=19
|
-0.9 Millimeter of mercury (mmHg)
Standard Deviation 12.33
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 100, n=7
|
-3.6 Millimeter of mercury (mmHg)
Standard Deviation 9.95
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 104, n=1
|
-20.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Blood Pressure
Su SBP Mon 108, n=10
|
-4.4 Millimeter of mercury (mmHg)
Standard Deviation 16.60
|
|
Change From Baseline in Blood Pressure
St SBP Mon 1, n=173
|
0.3 Millimeter of mercury (mmHg)
Standard Deviation 14.10
|
|
Change From Baseline in Blood Pressure
St SBP Mon 3, n=159
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 15.38
|
|
Change From Baseline in Blood Pressure
St SBP Mon 6, n=143
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 14.35
|
|
Change From Baseline in Blood Pressure
St SBP Mon 9, n=125
|
0.2 Millimeter of mercury (mmHg)
Standard Deviation 14.84
|
|
Change From Baseline in Blood Pressure
St SBP Mon 12, n=170
|
1.4 Millimeter of mercury (mmHg)
Standard Deviation 15.25
|
|
Change From Baseline in Blood Pressure
St SBP Mon 16, n=104
|
0.1 Millimeter of mercury (mmHg)
Standard Deviation 14.69
|
|
Change From Baseline in Blood Pressure
St SBP Mon 20, n=100
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 16.05
|
|
Change From Baseline in Blood Pressure
St SBP Mon 24, n=110
|
3.8 Millimeter of mercury (mmHg)
Standard Deviation 17.42
|
|
Change From Baseline in Blood Pressure
St SBP Mon 28, n=87
|
1.6 Millimeter of mercury (mmHg)
Standard Deviation 15.53
|
|
Change From Baseline in Blood Pressure
St SBP Mon 32, n=84
|
3.1 Millimeter of mercury (mmHg)
Standard Deviation 17.06
|
|
Change From Baseline in Blood Pressure
St SBP Mon 36, n=91
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 15.20
|
|
Change From Baseline in Blood Pressure
St SBP Mon 40, n=77
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 16.79
|
|
Change From Baseline in Blood Pressure
St SBP Mon 44, n=75
|
2.7 Millimeter of mercury (mmHg)
Standard Deviation 15.80
|
|
Change From Baseline in Blood Pressure
St SBP Mon 48, n=81
|
3.3 Millimeter of mercury (mmHg)
Standard Deviation 14.51
|
|
Change From Baseline in Blood Pressure
St SBP Mon 52, n=67
|
3.9 Millimeter of mercury (mmHg)
Standard Deviation 18.37
|
|
Change From Baseline in Blood Pressure
St SBP Mon 56, n=62
|
2.7 Millimeter of mercury (mmHg)
Standard Deviation 13.99
|
|
Change From Baseline in Blood Pressure
St SBP Mon 60, n=69
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 13.41
|
|
Change From Baseline in Blood Pressure
St SBP Mon 64, n=49
|
2.4 Millimeter of mercury (mmHg)
Standard Deviation 17.27
|
|
Change From Baseline in Blood Pressure
St SBP Mon 68, n=45
|
-0.3 Millimeter of mercury (mmHg)
Standard Deviation 15.98
|
|
Change From Baseline in Blood Pressure
St SBP Mon 72, n=56
|
2.3 Millimeter of mercury (mmHg)
Standard Deviation 17.23
|
|
Change From Baseline in Blood Pressure
St SBP Mon 76, n=30
|
-4.5 Millimeter of mercury (mmHg)
Standard Deviation 17.63
|
|
Change From Baseline in Blood Pressure
St SBP Mon 80, n=23
|
-1.1 Millimeter of mercury (mmHg)
Standard Deviation 13.70
|
|
Change From Baseline in Blood Pressure
St SBP Mon 84, n=34
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 13.46
|
|
Change From Baseline in Blood Pressure
St SBP Mon 88, n=17
|
2.1 Millimeter of mercury (mmHg)
Standard Deviation 11.89
|
|
Change From Baseline in Blood Pressure
St SBP Mon 92, n=16
|
-4.9 Millimeter of mercury (mmHg)
Standard Deviation 14.38
|
|
Change From Baseline in Blood Pressure
St SBP Mon 96, n=19
|
0.5 Millimeter of mercury (mmHg)
Standard Deviation 12.24
|
|
Change From Baseline in Blood Pressure
St SBP Mon 100, n=7
|
-4.6 Millimeter of mercury (mmHg)
Standard Deviation 11.16
|
|
Change From Baseline in Blood Pressure
St SBP Mon 104, n=1
|
-22.0 Millimeter of mercury (mmHg)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Blood Pressure
St SBP Mon 108, n=10
|
-5.5 Millimeter of mercury (mmHg)
Standard Deviation 7.14
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Heart Rate
Su HR Mon 96, n=19
|
-1.0 Beats per Minute
Standard Deviation 14.35
|
|
Change From Baseline in Heart Rate
Su HR Mon 100, n=7
|
-8.3 Beats per Minute
Standard Deviation 19.10
|
|
Change From Baseline in Heart Rate
Su HR Mon 104, n=1
|
-6.0 Beats per Minute
Standard Deviation NA
Standard Deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Heart Rate
Su HR Mon 108, n=10
|
-3.4 Beats per Minute
Standard Deviation 12.86
|
|
Change From Baseline in Heart Rate
Su HR Mon 1, n=174
|
-1.0 Beats per Minute
Standard Deviation 10.21
|
|
Change From Baseline in Heart Rate
Su HR Mon 3, n=159
|
-0.7 Beats per Minute
Standard Deviation 11.34
|
|
Change From Baseline in Heart Rate
Su HR Mon 6, n=143
|
-0.2 Beats per Minute
Standard Deviation 11.57
|
|
Change From Baseline in Heart Rate
Su HR Mon 9, n=124
|
-1.0 Beats per Minute
Standard Deviation 11.33
|
|
Change From Baseline in Heart Rate
Su HR Mon 12, n=173
|
-0.1 Beats per Minute
Standard Deviation 12.02
|
|
Change From Baseline in Heart Rate
Su HR Mon 16, n=104
|
1.1 Beats per Minute
Standard Deviation 12.51
|
|
Change From Baseline in Heart Rate
Su HR Mon 20, n=100
|
1.1 Beats per Minute
Standard Deviation 12.10
|
|
Change From Baseline in Heart Rate
Su HR Mon 24, n=112
|
-0.1 Beats per Minute
Standard Deviation 15.92
|
|
Change From Baseline in Heart Rate
Su HR Mon 32, n=85
|
0.4 Beats per Minute
Standard Deviation 12.56
|
|
Change From Baseline in Heart Rate
Su HR Mon 36, n=92
|
-1.7 Beats per Minute
Standard Deviation 11.38
|
|
Change From Baseline in Heart Rate
Su HR Mon 40, n=78
|
-0.6 Beats per Minute
Standard Deviation 13.28
|
|
Change From Baseline in Heart Rate
Su HR Mon 44, n=76
|
-2.8 Beats per Minute
Standard Deviation 12.47
|
|
Change From Baseline in Heart Rate
Su HR Mon 48, n=82
|
-2.1 Beats per Minute
Standard Deviation 11.25
|
|
Change From Baseline in Heart Rate
Su HR Mon 52, n=67
|
-1.5 Beats per Minute
Standard Deviation 11.39
|
|
Change From Baseline in Heart Rate
Su HR Mon 56, n=63
|
-1.8 Beats per Minute
Standard Deviation 12.30
|
|
Change From Baseline in Heart Rate
Su HR Mon 60, n=70
|
-1.2 Beats per Minute
Standard Deviation 12.89
|
|
Change From Baseline in Heart Rate
Su HR Mon 64, n=50
|
-2.1 Beats per Minute
Standard Deviation 11.54
|
|
Change From Baseline in Heart Rate
Su HR Mon 68, n=45
|
1.2 Beats per Minute
Standard Deviation 13.87
|
|
Change From Baseline in Heart Rate
Su HR Mon 72, n=57
|
-1.9 Beats per Minute
Standard Deviation 12.32
|
|
Change From Baseline in Heart Rate
Su HR Mon 76, n=31
|
-1.6 Beats per Minute
Standard Deviation 13.05
|
|
Change From Baseline in Heart Rate
Su HR Mon 80, n=24
|
-2.2 Beats per Minute
Standard Deviation 11.93
|
|
Change From Baseline in Heart Rate
Su HR Mon 84, n=36
|
-2.4 Beats per Minute
Standard Deviation 12.56
|
|
Change From Baseline in Heart Rate
Su HR Mon 88, n=17
|
1.5 Beats per Minute
Standard Deviation 13.98
|
|
Change From Baseline in Heart Rate
Su HR Mon 92, n=16
|
-2.7 Beats per Minute
Standard Deviation 11.52
|
|
Change From Baseline in Heart Rate
St HR Mon 1, n=174
|
0.7 Beats per Minute
Standard Deviation 11.97
|
|
Change From Baseline in Heart Rate
St HR Mon 3, n=158
|
1.0 Beats per Minute
Standard Deviation 12.02
|
|
Change From Baseline in Heart Rate
St HR Mon 6, n=143
|
1.6 Beats per Minute
Standard Deviation 12.82
|
|
Change From Baseline in Heart Rate
St HR Mon 9, n=124
|
1.1 Beats per Minute
Standard Deviation 12.99
|
|
Change From Baseline in Heart Rate
St HR Mon 12, n=170
|
2.3 Beats per Minute
Standard Deviation 12.64
|
|
Change From Baseline in Heart Rate
St HR Mon 16, n=104
|
2.5 Beats per Minute
Standard Deviation 12.71
|
|
Change From Baseline in Heart Rate
St HR Mon 20, n=100
|
0.2 Beats per Minute
Standard Deviation 13.35
|
|
Change From Baseline in Heart Rate
St HR Mon 24, n=110
|
2.6 Beats per Minute
Standard Deviation 17.38
|
|
Change From Baseline in Heart Rate
St HR Mon 28, n=87
|
-0.8 Beats per Minute
Standard Deviation 13.79
|
|
Change From Baseline in Heart Rate
St HR Mon 32, n=84
|
1.7 Beats per Minute
Standard Deviation 11.71
|
|
Change From Baseline in Heart Rate
St HR Mon 36, n=91
|
-0.4 Beats per Minute
Standard Deviation 12.40
|
|
Change From Baseline in Heart Rate
St HR Mon 40, n=77
|
0.4 Beats per Minute
Standard Deviation 11.51
|
|
Change From Baseline in Heart Rate
St HR Mon 44, n=75
|
-0.3 Beats per Minute
Standard Deviation 12.74
|
|
Change From Baseline in Heart Rate
St HR Mon 48, n=81
|
-1.9 Beats per Minute
Standard Deviation 12.57
|
|
Change From Baseline in Heart Rate
St HR Mon 52, n=67
|
-0.3 Beats per Minute
Standard Deviation 12.71
|
|
Change From Baseline in Heart Rate
St HR Mon 56, n=62
|
1.3 Beats per Minute
Standard Deviation 12.21
|
|
Change From Baseline in Heart Rate
St HR Mon 60, n=69
|
-0.2 Beats per Minute
Standard Deviation 14.44
|
|
Change From Baseline in Heart Rate
St HR Mon 64, n=49
|
1.3 Beats per Minute
Standard Deviation 14.29
|
|
Change From Baseline in Heart Rate
St HR Mon 68, n=45
|
4.1 Beats per Minute
Standard Deviation 14.77
|
|
Change From Baseline in Heart Rate
St HR Mon 72, n=56
|
0.4 Beats per Minute
Standard Deviation 12.10
|
|
Change From Baseline in Heart Rate
St HR Mon 76, n=30
|
1.9 Beats per Minute
Standard Deviation 13.26
|
|
Change From Baseline in Heart Rate
St HR Mon 80, n=23
|
3.0 Beats per Minute
Standard Deviation 11.81
|
|
Change From Baseline in Heart Rate
St HR Mon 84, n=35
|
0.2 Beats per Minute
Standard Deviation 13.24
|
|
Change From Baseline in Heart Rate
St HR Mon 88, n=17
|
3.6 Beats per Minute
Standard Deviation 12.24
|
|
Change From Baseline in Heart Rate
St HR Mon 92, n=16
|
3.1 Beats per Minute
Standard Deviation 10.13
|
|
Change From Baseline in Heart Rate
St HR Mon 96, n=19
|
3.2 Beats per Minute
Standard Deviation 13.12
|
|
Change From Baseline in Heart Rate
St HR Mon 100, n=7
|
2.6 Beats per Minute
Standard Deviation 10.72
|
|
Change From Baseline in Heart Rate
St HR Mon 104, n=1
|
0.0 Beats per Minute
Standard Deviation NA
Standard Deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Heart Rate
St HR Mon 108, n=10
|
-5.4 Beats per Minute
Standard Deviation 11.37
|
|
Change From Baseline in Heart Rate
Su HR Mon 28, n=88
|
-0.8 Beats per Minute
Standard Deviation 13.11
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Body Temperature
Temperature, Mon 1, n=174
|
-0.04 Degree Celsius
Standard Deviation 0.437
|
|
Change From Baseline in Body Temperature
Temperature, Mon 3, n=158
|
-0.08 Degree Celsius
Standard Deviation 0.460
|
|
Change From Baseline in Body Temperature
Temperature, Mon 6, n=142
|
-0.05 Degree Celsius
Standard Deviation 0.455
|
|
Change From Baseline in Body Temperature
Temperature, Mon 9, n=124
|
-0.06 Degree Celsius
Standard Deviation 0.479
|
|
Change From Baseline in Body Temperature
Temperature, Mon 12, n=172
|
-0.07 Degree Celsius
Standard Deviation 0.489
|
|
Change From Baseline in Body Temperature
Temperature, Mon 16, n=102
|
-0.01 Degree Celsius
Standard Deviation 0.477
|
|
Change From Baseline in Body Temperature
Temperature, Mon 20, n=98
|
-0.00 Degree Celsius
Standard Deviation 0.495
|
|
Change From Baseline in Body Temperature
Temperature, Mon 24, n=110
|
-0.07 Degree Celsius
Standard Deviation 0.532
|
|
Change From Baseline in Body Temperature
Temperature, Mon 28, n=86
|
-0.08 Degree Celsius
Standard Deviation 0.457
|
|
Change From Baseline in Body Temperature
Temperature, Mon 32, n=85
|
-0.09 Degree Celsius
Standard Deviation 0.456
|
|
Change From Baseline in Body Temperature
Temperature, Mon 36, n=92
|
-0.13 Degree Celsius
Standard Deviation 0.543
|
|
Change From Baseline in Body Temperature
Temperature, Mon 40, n=77
|
-0.12 Degree Celsius
Standard Deviation 0.492
|
|
Change From Baseline in Body Temperature
Temperature, Mon 44, n=76
|
-0.07 Degree Celsius
Standard Deviation 0.523
|
|
Change From Baseline in Body Temperature
Temperature, Mon 48, n=82
|
-0.06 Degree Celsius
Standard Deviation 0.525
|
|
Change From Baseline in Body Temperature
Temperature, Mon 52, n=68
|
-0.13 Degree Celsius
Standard Deviation 0.439
|
|
Change From Baseline in Body Temperature
Temperature, Mon 56, n=63
|
-0.09 Degree Celsius
Standard Deviation 0.566
|
|
Change From Baseline in Body Temperature
Temperature, Mon 60, n=70
|
-0.02 Degree Celsius
Standard Deviation 0.436
|
|
Change From Baseline in Body Temperature
Temperature, Mon 64, n=48
|
-0.12 Degree Celsius
Standard Deviation 0.451
|
|
Change From Baseline in Body Temperature
Temperature, Mon 68, n=45
|
-0.01 Degree Celsius
Standard Deviation 0.497
|
|
Change From Baseline in Body Temperature
Temperature, Mon 72, n=57
|
-0.06 Degree Celsius
Standard Deviation 0.433
|
|
Change From Baseline in Body Temperature
Temperature, Mon 76, n=31
|
-0.04 Degree Celsius
Standard Deviation 0.506
|
|
Change From Baseline in Body Temperature
Temperature, Mon 80, n=24
|
-0.08 Degree Celsius
Standard Deviation 0.472
|
|
Change From Baseline in Body Temperature
Temperature, Mon 84, n=36
|
-0.19 Degree Celsius
Standard Deviation 0.481
|
|
Change From Baseline in Body Temperature
Temperature, Mon 88, n=17
|
-0.20 Degree Celsius
Standard Deviation 0.496
|
|
Change From Baseline in Body Temperature
Temperature, Mon 92, n=16
|
-0.14 Degree Celsius
Standard Deviation 0.542
|
|
Change From Baseline in Body Temperature
Temperature, Mon 96, n=19
|
-0.26 Degree Celsius
Standard Deviation 0.512
|
|
Change From Baseline in Body Temperature
Temperature, Mon 100, n=7
|
-0.14 Degree Celsius
Standard Deviation 0.690
|
|
Change From Baseline in Body Temperature
Temperature, Mon 104, n=1
|
1.00 Degree Celsius
Standard Deviation NA
Standard Deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Body Temperature
Temperature, Mon 108, n=10
|
-0.15 Degree Celsius
Standard Deviation 0.645
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Weight
Weight, Mon 1, n=172
|
1.94 Kilograms
Standard Deviation 3.691
|
|
Change From Baseline in Weight
Weight, Mon 3, n=159
|
1.85 Kilograms
Standard Deviation 6.455
|
|
Change From Baseline in Weight
Weight, Mon 6, n=143
|
1.68 Kilograms
Standard Deviation 5.315
|
|
Change From Baseline in Weight
Weight, Mon 9, n=123
|
1.57 Kilograms
Standard Deviation 6.149
|
|
Change From Baseline in Weight
Weight, Mon 12, n=171
|
1.31 Kilograms
Standard Deviation 6.961
|
|
Change From Baseline in Weight
Weight, Mon 16, n=104
|
2.17 Kilograms
Standard Deviation 8.799
|
|
Change From Baseline in Weight
Weight, Mon 20, n=101
|
1.62 Kilograms
Standard Deviation 7.786
|
|
Change From Baseline in Weight
Weight, Mon 24, n=111
|
1.21 Kilograms
Standard Deviation 8.178
|
|
Change From Baseline in Weight
Weight, Mon 28, n=88
|
0.35 Kilograms
Standard Deviation 8.859
|
|
Change From Baseline in Weight
Weight, Mon 32, n=85
|
0.07 Kilograms
Standard Deviation 9.084
|
|
Change From Baseline in Weight
Weight, Mon 36, n=92
|
0.61 Kilograms
Standard Deviation 8.066
|
|
Change From Baseline in Weight
Weight, Mon 40, n=78
|
0.84 Kilograms
Standard Deviation 9.106
|
|
Change From Baseline in Weight
Weight, Mon 44, n=76
|
0.88 Kilograms
Standard Deviation 8.137
|
|
Change From Baseline in Weight
Weight, Mon 48, n=82
|
0.73 Kilograms
Standard Deviation 9.097
|
|
Change From Baseline in Weight
Weight, Mon 52, n=68
|
1.10 Kilograms
Standard Deviation 9.401
|
|
Change From Baseline in Weight
Weight, Mon 56, n=62
|
1.28 Kilograms
Standard Deviation 8.998
|
|
Change From Baseline in Weight
Weight, Mon 60, n=69
|
0.94 Kilograms
Standard Deviation 9.335
|
|
Change From Baseline in Weight
Weight, Mon 64, n=49
|
2.13 Kilograms
Standard Deviation 10.004
|
|
Change From Baseline in Weight
Weight, Mon 68, n=44
|
2.77 Kilograms
Standard Deviation 9.79
|
|
Change From Baseline in Weight
Weight, Mon 72, n=57
|
0.85 Kilograms
Standard Deviation 10.701
|
|
Change From Baseline in Weight
Weight, Mon 76, n=31
|
3.30 Kilograms
Standard Deviation 8.260
|
|
Change From Baseline in Weight
Weight, Mon 80, n=24
|
1.48 Kilograms
Standard Deviation 7.899
|
|
Change From Baseline in Weight
Weight, Mon 84, n=36
|
2.47 Kilograms
Standard Deviation 10.022
|
|
Change From Baseline in Weight
Weight, Mon 88, n=17
|
1.45 Kilograms
Standard Deviation 9.036
|
|
Change From Baseline in Weight
Weight, Mon 92, n=16
|
1.64 Kilograms
Standard Deviation 7.571
|
|
Change From Baseline in Weight
Weight, Mon 96, n=19
|
0.48 Kilograms
Standard Deviation 9.380
|
|
Change From Baseline in Weight
Weight, Mon 100, n=7
|
4.31 Kilograms
Standard Deviation 7.006
|
|
Change From Baseline in Weight
Weight, Mon 104, n=1
|
2.10 Kilograms
Standard Deviation NA
Standard Deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Weight
Weight, Mon 108, n=10
|
3.18 Kilograms
Standard Deviation 5.743
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 14.20
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 25.00
|
|
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 24.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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).
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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).
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 1, n=167
|
-1.3 Degree
Standard Deviation 14.34
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 3, n=151
|
-2.9 Degree
Standard Deviation 15.94
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 6, n=134
|
-1.5 Degree
Standard Deviation 11.50
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 9, n=118
|
-2.3 Degree
Standard Deviation 11.8
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 12, n=160
|
-3.1 Degree
Standard Deviation 13.72
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 24, n=104
|
-1.9 Degree
Standard Deviation 13.03
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 36, n=87
|
-2.5 Degree
Standard Deviation 11.43
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 48, n=77
|
-3.4 Degree
Standard Deviation 19.82
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 60, n=68
|
-8.0 Degree
Standard Deviation 14.50
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 84, n=34
|
-4.1 Degree
Standard Deviation 16.09
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 96, n=18
|
-4.9 Degree
Standard Deviation 8.53
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 108, n=10
|
-7.0 Degree
Standard Deviation 8.81
|
|
Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
QRS axis, Mon 72, n=52
|
-4.0 Degree
Standard Deviation 12.31
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.290
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.0270
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.0200
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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 0.0210
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.2000
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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 0.1230
|
|
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
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.5920
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.5410
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.6170
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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 0.1730
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.1720
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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 0.2400
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 40.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.1230
|
|
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
|
|
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
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 39.60
|
|
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
|
|
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
|
|
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
|
|
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 46.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.500
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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..
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell Count
RBC, Mon 16, n=99
|
-0.04 10^12 cells/Liter(L)
Standard Deviation 0.320
|
|
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
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell Count
RBC, Mon 24, n=110
|
-0.01 10^12 cells/Liter(L)
Standard Deviation 0.290
|
|
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
|
|
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
|
|
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
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell Count
RBC, Mon 40, n=78
|
-0.11 10^12 cells/Liter(L)
Standard Deviation 0.320
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell Count
RBC, Mon 92, n=15
|
0.14 10^12 cells/Liter(L)
Standard Deviation 0.300
|
|
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
|
|
Change From Baseline in Hematology Parameter-Red Blood Cell Count
RBC, Mon 104, n=1
|
0.30 10^12 cells/Liter(L)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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).
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 1, n=165
|
-0.009 Volume/Volume (v/v)
Standard Deviation 0.0272
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 2, n=15
|
-0.001 Volume/Volume (v/v)
Standard Deviation 0.0210
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 3, n=153
|
-0.007 Volume/Volume (v/v)
Standard Deviation 0.0287
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 4, n=26
|
-0.012 Volume/Volume (v/v)
Standard Deviation 0.0293
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 9, n=120
|
-0.006 Volume/Volume (v/v)
Standard Deviation 0.0272
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 10, n=55
|
-0.002 Volume/Volume (v/v)
Standard Deviation 0.0295
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 12, n=162
|
-0.001 Volume/Volume (v/v)
Standard Deviation 0.0291
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 16, n=98
|
-0.005 Volume/Volume (v/v)
Standard Deviation 0.0292
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 28, n=84
|
-0.004 Volume/Volume (v/v)
Standard Deviation 0.0250
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 32, n=85
|
-0.001 Volume/Volume (v/v)
Standard Deviation 0.0273
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 48, n=76
|
-0.009 Volume/Volume (v/v)
Standard Deviation 0.0376
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 52, n=67
|
0.001 Volume/Volume (v/v)
Standard Deviation 0.0347
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 56, n=62
|
-0.001 Volume/Volume (v/v)
Standard Deviation 0.0335
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 60, n=71
|
0.005 Volume/Volume (v/v)
Standard Deviation 0.0352
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 64, n=49
|
0.004 Volume/Volume (v/v)
Standard Deviation 0.0332
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 68, n=44
|
0.011 Volume/Volume (v/v)
Standard Deviation 0.0345
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 72, n=53
|
0.008 Volume/Volume (v/v)
Standard Deviation 0.0346
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 76, n=31
|
0.014 Volume/Volume (v/v)
Standard Deviation 0.0350
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 80, n=23
|
0.009 Volume/Volume (v/v)
Standard Deviation 0.0272
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 96, n=18
|
0.017 Volume/Volume (v/v)
Standard Deviation 0.0311
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 100, n=6
|
0.028 Volume/Volume (v/v)
Standard Deviation 0.0232
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 108, n=9
|
0.030 Volume/Volume (v/v)
Standard Deviation 0.0283
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 6, n=136
|
-0.004 Volume/Volume (v/v)
Standard Deviation 0.0262
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 8, n=41
|
-0.005 Volume/Volume (v/v)
Standard Deviation 0.0248
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 20, n=94
|
-0.001 Volume/Volume (v/v)
Standard Deviation 0.0280
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 24, n=109
|
-0.002 Volume/Volume (v/v)
Standard Deviation 0.0267
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 36, n=91
|
-0.005 Volume/Volume (v/v)
Standard Deviation 0.0298
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 40, n=77
|
-0.004 Volume/Volume (v/v)
Standard Deviation 0.0319
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 44, n=73
|
-0.002 Volume/Volume (v/v)
Standard Deviation 0.0287
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 84, n=34
|
0.007 Volume/Volume (v/v)
Standard Deviation 0.0379
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 88, n=16
|
0.017 Volume/Volume (v/v)
Standard Deviation 0.0332
|
|
Change From Baseline in Haematocrit
Haematocrit, Mon 92, n=14
|
0.027 Volume/Volume (v/v)
Standard Deviation 0.0267
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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..
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 1, n=169
|
-3.2 Grams/Liter (g/L)
Standard Deviation 8.97
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 12, n=167
|
-0.7 Grams/Liter (g/L)
Standard Deviation 9.61
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 16, n=98
|
-2.5 Grams/Liter (g/L)
Standard Deviation 9.96
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 20, n=96
|
-1.4 Grams/Liter (g/L)
Standard Deviation 9.34
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 40, n=78
|
-3.4 Grams/Liter (g/L)
Standard Deviation 10.88
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 44, n=74
|
-2.3 Grams/Liter (g/L)
Standard Deviation 9.74
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 48, n=79
|
-4.3 Grams/Liter (g/L)
Standard Deviation 11.13
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 60, n=71
|
-2.9 Grams/Liter (g/L)
Standard Deviation 10.15
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 64, n=49
|
-3.7 Grams/Liter (g/L)
Standard Deviation 10.55
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 68, n=44
|
-2.0 Grams/Liter (g/L)
Standard Deviation 10.41
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 92, n=15
|
0.7 Grams/Liter (g/L)
Standard Deviation 9.14
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 96, n=19
|
-2.1 Grams/Liter (g/L)
Standard Deviation 7.57
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 100, n=7
|
2.6 Grams/Liter (g/L)
Standard Deviation 8.87
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 104, n=1
|
8.0 Grams/Liter (g/L)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 108, n=10
|
0.5 Grams/Liter (g/L)
Standard Deviation 7.47
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 2, n=15
|
-0.9 Grams/Liter (g/L)
Standard Deviation 7.26
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 3, n=154
|
-2.6 Grams/Liter (g/L)
Standard Deviation 9.41
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 4, n=26
|
-5.7 Grams/Liter (g/L)
Standard Deviation 10.44
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 6, n=137
|
-2.2 Grams/Liter (g/L)
Standard Deviation 9.31
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 8, n=43
|
-1.9 Grams/Liter (g/L)
Standard Deviation 9.40
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 9, n=122
|
-2.9 Grams/Liter (g/L)
Standard Deviation 9.45
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 10, n=55
|
-0.9 Grams/Liter (g/L)
Standard Deviation 9.26
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 24, n=110
|
-2.2 Grams/Liter (g/L)
Standard Deviation 8.76
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 28, n=85
|
-3.2 Grams/Liter (g/L)
Standard Deviation 9.49
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 32, n=86
|
-2.2 Grams/Liter (g/L)
Standard Deviation 8.84
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 36, n=91
|
-3.3 Grams/Liter (g/L)
Standard Deviation 10.04
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 52, n=68
|
-2.0 Grams/Liter (g/L)
Standard Deviation 9.51
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 56, n=63
|
-2.8 Grams/Liter (g/L)
Standard Deviation 9.33
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 72, n=53
|
-3.8 Grams/Liter (g/L)
Standard Deviation 11.03
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 76, n=31
|
-3.1 Grams/Liter (g/L)
Standard Deviation 11.65
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 80, n=24
|
-3.7 Grams/Liter (g/L)
Standard Deviation 9.24
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 84, n=35
|
-3.8 Grams/Liter (g/L)
Standard Deviation 11.97
|
|
Change From Baseline in Haemoglobin
Haemoglobin, Mon 88, n=16
|
-3.1 Grams/Liter (g/L)
Standard Deviation 9.76
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 22.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 8.50
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 29.20
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 8.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.1170
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.7230
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.700
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.2160
|
|
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 0.2330
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.2970
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.400
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.430
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 3.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.9430
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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 2.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 3.70
|
|
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 4.00
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 3.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.6420
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.6810
|
|
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
|
|
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
|
|
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 1.8800
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.1180
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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 0.7230
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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 12.20
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 16.60
|
|
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 14.90
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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 14.40
|
|
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
|
|
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
|
|
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
|
|
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 4.40
|
|
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 4.10
|
|
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
|
|
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
|
|
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 4.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 45.40
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
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
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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)
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 76, n=30
|
0.8 Grams per liter (g/L)
Standard Deviation 4.93
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 80, n=22
|
0.3 Grams per liter (g/L)
Standard Deviation 4.82
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 1, n=170
|
-1.1 Grams per liter (g/L)
Standard Deviation 4.44
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 3, n=152
|
-0.5 Grams per liter (g/L)
Standard Deviation 4.87
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 6, n=137
|
-1.0 Grams per liter (g/L)
Standard Deviation 4.77
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 9, n=123
|
-0.8 Grams per liter (g/L)
Standard Deviation 4.60
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 12, n=169
|
0.2 Grams per liter (g/L)
Standard Deviation 4.45
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 16, n=100
|
0.3 Grams per liter (g/L)
Standard Deviation 5.15
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 20, n=97
|
0.8 Grams per liter (g/L)
Standard Deviation 4.64
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 24, n=109
|
0.2 Grams per liter (g/L)
Standard Deviation 4.67
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 28, n=87
|
-0.2 Grams per liter (g/L)
Standard Deviation 4.52
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 32, n=85
|
0.1 Grams per liter (g/L)
Standard Deviation 4.55
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 36, n=89
|
-1.1 Grams per liter (g/L)
Standard Deviation 4.48
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 40, n=77
|
-1.1 Grams per liter (g/L)
Standard Deviation 4.46
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 44, n=73
|
-0.1 Grams per liter (g/L)
Standard Deviation 4.72
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 48, n=79
|
-1.3 Grams per liter (g/L)
Standard Deviation 4.34
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 52, n=67
|
-0.7 Grams per liter (g/L)
Standard Deviation 4.67
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 56, n=62
|
-1.1 Grams per liter (g/L)
Standard Deviation 4.32
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 60, n=69
|
-0.7 Grams per liter (g/L)
Standard Deviation 4.75
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 64, n=49
|
-0.2 Grams per liter (g/L)
Standard Deviation 4.86
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 68, n=41
|
0.6 Grams per liter (g/L)
Standard Deviation 4.82
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 72, n=51
|
-0.7 Grams per liter (g/L)
Standard Deviation 5.17
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 84, n=34
|
0.7 Grams per liter (g/L)
Standard Deviation 5.90
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 88, n=15
|
0.4 Grams per liter (g/L)
Standard Deviation 5.29
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 92, n=15
|
1.0 Grams per liter (g/L)
Standard Deviation 4.09
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 96, n=18
|
0.9 Grams per liter (g/L)
Standard Deviation 3.20
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 100, n=6
|
2.0 Grams per liter (g/L)
Standard Deviation 4.77
|
|
Change From Baseline in Chemistry Parameter-Total Protein
TP Mon 104, n=1
|
7.0 Grams per liter (g/L)
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed.
|
|
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 outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 1, n=166
|
-0.0018 Dimensionless unit
Standard Deviation 0.00848
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 3, n=157
|
-0.0016 Dimensionless unit
Standard Deviation 0.00852
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 6, n=137
|
0.0002 Dimensionless unit
Standard Deviation 0.00930
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 9, n=121
|
0.0002 Dimensionless unit
Standard Deviation 0.00933
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 12, n=170
|
-0.0000 Dimensionless unit
Standard Deviation 0.00937
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 16, n=100
|
0.0006 Dimensionless unit
Standard Deviation 0.00960
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 20, n=97
|
0.0008 Dimensionless unit
Standard Deviation 0.00964
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 24, n=109
|
-0.0012 Dimensionless unit
Standard Deviation 0.00985
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 28, n=86
|
-0.0003 Dimensionless unit
Standard Deviation 0.01032
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 32, n=82
|
-0.0006 Dimensionless unit
Standard Deviation 0.00935
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 36, n=89
|
-0.0024 Dimensionless unit
Standard Deviation 0.0086
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 40, n=76
|
-0.0005 Dimensionless unit
Standard Deviation 0.00865
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 44, n=72
|
-0.0007 Dimensionless unit
Standard Deviation 0.00867
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 48, n=80
|
-0.0015 Dimensionless unit
Standard Deviation 0.00941
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 52, n=67
|
0.0002 Dimensionless unit
Standard Deviation 0.00972
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 56, n=62
|
-0.0003 Dimensionless unit
Standard Deviation 0.00899
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 60, n=68
|
-0.0023 Dimensionless unit
Standard Deviation 0.00893
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 64, n=49
|
-0.0022 Dimensionless unit
Standard Deviation 0.00938
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 68, n=42
|
-0.0022 Dimensionless unit
Standard Deviation 0.00822
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 72, n=53
|
-0.0015 Dimensionless unit
Standard Deviation 0.01006
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 76, n=31
|
-0.0024 Dimensionless unit
Standard Deviation 0.00822
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 80, n=23
|
-0.0021 Dimensionless unit
Standard Deviation 0.00867
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 84, n=35
|
-0.0028 Dimensionless unit
Standard Deviation 0.00862
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 88, n=17
|
-0.0055 Dimensionless unit
Standard Deviation 0.00833
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 92, n=16
|
-0.0030 Dimensionless unit
Standard Deviation 0.01116
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 96, n=19
|
-0.0039 Dimensionless unit
Standard Deviation 0.00956
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 100, n=7
|
-0.0013 Dimensionless unit
Standard Deviation 0.00886
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 104, n=1
|
-0.0150 Dimensionless unit
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Urine Specific Gravity
USG, Mon 108, n=10
|
-0.0014 Dimensionless unit
Standard Deviation 0.01032
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 92, n=16
|
0.28 pH units
Standard Deviation 1.224
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 1, n=166
|
-0.13 pH units
Standard Deviation 0.721
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 3, n=157
|
-0.18 pH units
Standard Deviation 0.791
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 6, n=137
|
-0.13 pH units
Standard Deviation 0.767
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 9, n=121
|
-0.17 pH units
Standard Deviation 0.771
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 12, n=170
|
-0.11 pH units
Standard Deviation 0.793
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 16, n=100
|
-0.05 pH units
Standard Deviation 0.764
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 20, n=97
|
-0.20 pH units
Standard Deviation 0.886
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 24, n=109
|
-0.09 pH units
Standard Deviation 0.713
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 28, n=86
|
-0.01 pH units
Standard Deviation 0.893
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 32, n=82
|
-0.10 pH units
Standard Deviation 0.768
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 36, n=89
|
0.12 pH units
Standard Deviation 0.83
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 40, n=76
|
0.09 pH units
Standard Deviation 0.842
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 44, n=72
|
0.12 pH units
Standard Deviation 0.767
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 48, n=80
|
0.19 pH units
Standard Deviation 0.828
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 52, n=67
|
0.17 pH units
Standard Deviation 0.851
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 56, n=62
|
0.06 pH units
Standard Deviation 0.769
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 60, n=68
|
0.24 pH units
Standard Deviation 0.896
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 64, n=49
|
0.19 pH units
Standard Deviation 0.934
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 68, n=42
|
0.12 pH units
Standard Deviation 0.825
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 72, n=53
|
0.16 pH units
Standard Deviation 0.842
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 76, n=31
|
0.13 pH units
Standard Deviation 1.000
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 80, n=23
|
0.24 pH units
Standard Deviation 0.890
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 84, n=36
|
0.00 pH units
Standard Deviation 0.862
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 88, n=17
|
0.21 pH units
Standard Deviation 1.032
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 96, n=19
|
0.26 pH units
Standard Deviation 0.888
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 100, n=7
|
0.14 pH units
Standard Deviation 1.180
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 104, n=1
|
0.50 pH units
Standard Deviation NA
Standard deviation value was not available as only one participant was analyzed
|
|
Change From Baseline in Urine Power of Hydrogen (pH)
UpH, Mon 108, n=10
|
0.65 pH units
Standard Deviation 0.747
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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)
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 60, n=65
|
20.1 Milliliter (mL)
Standard Deviation 85.81
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 1, n=152
|
6.5 Milliliter (mL)
Standard Deviation 60.92
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 3, n=146
|
5.8 Milliliter (mL)
Standard Deviation 59.69
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 12, n=144
|
-2.8 Milliliter (mL)
Standard Deviation 73.95
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 24, n=75
|
11.6 Milliliter (mL)
Standard Deviation 62.06
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 36, n=84
|
13.6 Milliliter (mL)
Standard Deviation 58.45
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 48, n=77
|
8.8 Milliliter (mL)
Standard Deviation 62.28
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 72, n=48
|
17.2 Milliliter (mL)
Standard Deviation 61.82
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 84, n=31
|
40.0 Milliliter (mL)
Standard Deviation 89.38
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 96, n=19
|
8.7 Milliliter (mL)
Standard Deviation 23.32
|
|
Change From Baseline in Post-void Residual Bladder Ultrasound Volume
PVR, Mon 108, n=10
|
17.4 Milliliter (mL)
Standard Deviation 60.89
|
PRIMARY outcome
Timeframe: Baseline and Up to Month 108Population: Safety Population
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)
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 6.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: Up to Month 108Population: Safety Population
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
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Abnormal Results in Physical Examination
Baseline, n=181
|
59 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 12, n=169
|
49 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 24, n=113
|
34 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 36, n=92
|
27 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 48, n=82
|
25 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 60, 69
|
32 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 72, n=56
|
31 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 84, n=36
|
25 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 96, n=19
|
10 Participants
|
|
Number of Participants With Abnormal Results in Physical Examination
Mon 108, n=10
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 108Population: Safety Population
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)
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 12, n= 171, AbCS
|
13 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 16, n= 104, AbNCS
|
23 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 92, n= 16, AbNCS
|
2 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Baseline, n= 173, AbNCS
|
60 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Baseline, n= 173, AbCS
|
11 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 1, n= 173, AbNCS
|
49 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 1, n= 173, AbCS
|
17 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 3, n= 159, AbNCS
|
42 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 3, n= 159, AbCS
|
9 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 6, n= 141, AbNCS
|
35 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 6, n= 141, AbCS
|
8 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 9, n= 125, AbNCS
|
32 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 9, n= 125, AbCS
|
9 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 12, n= 171, AbNCS
|
56 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 16, n= 104, AbCS
|
10 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 20, n= 98, AbNCS
|
28 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 20, n= 98, AbCS
|
6 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 24, n= 113, AbNCS
|
35 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 24, n= 113, AbCS
|
6 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 28, n= 87, AbNCS
|
23 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 28, n= 87, AbCS
|
6 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 32, n= 86, AbNCS
|
19 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 32, n= 86, AbCS
|
5 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 36, n= 92, AbNCS
|
28 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 36, n= 92, AbCS
|
6 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 40, n= 78, AbNCS
|
22 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 40, n= 78, AbCS
|
8 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 44, n= 76, AbNCS
|
25 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 44, n= 76, AbCS
|
3 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 48, n= 82, AbNCS
|
25 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 48, n= 82, AbCS
|
6 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 52, n= 67, AbNCS
|
19 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 52, n= 67, AbCS
|
4 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 56, n= 63, AbNCS
|
19 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 56, n= 63, AbCS
|
4 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 60, n= 68, AbNCS
|
27 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 60, n= 68, AbCS
|
3 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 64, n= 50, AbNCS
|
21 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 64, n= 50, AbCS
|
1 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 68, n= 44, AbNCS
|
15 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 68, n= 44, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 72, n= 56, AbNCS
|
20 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 72, n= 56, AbCS
|
4 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 76, n= 31, AbNCS
|
11 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 76, n= 31, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 80, n= 24, AbNCS
|
7 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 80, n= 24, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 84, n= 36, AbNCS
|
14 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 84, n= 36, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 88, n= 17, AbNCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 88, n= 17, AbCS
|
1 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 92, n= 16, AbCS
|
1 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 96, n= 19, AbNCS
|
4 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 96, n= 19, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 100, n= 7, AbNCS
|
2 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 100, n= 7, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 104, n= 1, AbNCS
|
1 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 104, n= 1, AbCS
|
0 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 108, n= 10, AbNCS
|
2 Participants
|
|
Number of Participants With Abnormal Results of Neurological Examination
Mon 108, n= 10, AbCS
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=36 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Pigmentation of Non-retinal Ocular Tissue
|
11 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=36 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Pigmentation of Retinal Ocular Tissue
|
14 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=24 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
|
2 Participants
|
PRIMARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 years and 9 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Overall Study
n=19 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Retinal pigmentary abnormality
|
1 Participants
|
|
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Pigmentary abnormality of macula
|
1 Participants
|
|
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Pigmentary abnormality of peripheral retina
|
3 Participants
|
|
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Non-retinal ocular pigmentary abnormality
|
4 Participants
|
PRIMARY outcome
Timeframe: 2 years 9 monthsPopulation: All SFUCP Subjects Population
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.
Outcome measures
| Measure |
Overall Study
n=19 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 years 9 monthsPopulation: All SFUCP Subjects Population
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.
Outcome measures
| Measure |
Overall Study
n=19 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Retinal Pigmentary Abnormality, n=1
|
317.0 Days
Interval 317.0 to 317.0
|
|
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Pigmentary Abnormality of Macula, n=1
|
163.0 Days
Interval 163.0 to 163.0
|
|
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Pigmentary Abnormality of Peripheral Retina, n=3
|
317.0 Days
Interval 197.0 to 794.0
|
|
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Non-Retinal Ocular Pigmentary Abnormality, n=4
|
180.0 Days
Interval 34.0 to 561.0
|
PRIMARY outcome
Timeframe: 2 years 9 monthsPopulation: All SFUCP Subjects Population
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.
Outcome measures
| Measure |
Overall Study
n=19 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
All, n=1
|
439.0 Days
Interval 439.0 to 439.0
|
|
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Skin, n=5
|
347.0 Days
Interval 203.0 to 952.0
|
|
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Lips, n=4
|
284.5 Days
Interval 133.0 to 590.0
|
|
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Nails,n=7
|
377.0 Days
Interval 203.0 to 762.0
|
|
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Mucosa, n=3
|
468.0 Days
Interval 133.0 to 541.0
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=179 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Percentage Change From Baseline in the 28-day Partial Seizure
|
-34.2 Percent change
Standard Deviation 68.70
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=179 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Responders
|
98 Participants
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=140 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants Who Were Seizure Free for Any 6 Continuous Months
|
20 Participants
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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.
Outcome measures
| Measure |
Overall Study
n=112 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Number of Participants Who Were Seizure Free for Any 12 Continuous Months
|
14 Participants
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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
Outcome measures
| Measure |
Overall Study
n=179 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Percentage of Seizure-free Days
|
75.7 Percentage of days
Standard Deviation 25.92
|
SECONDARY outcome
Timeframe: Assessed up to a maximum of 9 yearsPopulation: Safety Population
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)
Outcome measures
| Measure |
Overall Study
n=181 Participants
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Overall Study
Serious events: 48 serious events
Other events: 169 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Overall Study
n=181 participants at risk
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.1%
2/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Head injury
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Laceration
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Overdose
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Seizure
|
2.2%
4/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Epilepsy
|
1.1%
2/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Headache
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Hemiparesis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Postictal state
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Seizure cluster
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Status epilepticus
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Tonic convulsion
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Pneumonia
|
3.3%
6/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Anal abscess
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Appendicitis perforated
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Gastroenteritis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Confusional state
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Conversion disorder
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Depression
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Epileptic psychosis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Major depression
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Mental status changes
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Nervousness
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Somatic Symptom Disorder
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
2/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Gastritis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Insulinoma
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Hepatobiliary disorders
Biliary colic
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Hepatobiliary disorders
Cholecystitis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Investigations
Clostridium test positive
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Investigations
Liver function test abnormal
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Investigations
Transaminases increased
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
3/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Cardiac disorders
Angina unstable
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
General disorders
Idiosyncratic drug reaction
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.55%
1/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
Other adverse events
| Measure |
Overall Study
n=181 participants at risk
Participants received retigabine tablets for 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 treatment until withdrawal, withdrawn consent or switched to commercial product.
|
|---|---|
|
Nervous system disorders
Dizziness
|
30.4%
55/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Somnolence
|
24.3%
44/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Headache
|
23.2%
42/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Renal and urinary disorders
Urinary tract infection
|
20.4%
37/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Influenza
|
15.5%
28/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Tremor
|
12.2%
22/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
11.6%
21/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
General disorders
Fatigue
|
11.0%
20/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Seizure
|
8.8%
16/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
10.5%
19/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
9.9%
18/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
18/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
9.4%
17/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Dysarthria
|
9.4%
17/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Paraesthesia
|
9.4%
17/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
16/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Lip discolouration
|
8.8%
16/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.8%
16/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.3%
15/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
8.3%
15/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Pigmentation lip
|
8.3%
15/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
15/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Anxiety
|
7.7%
14/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Constipation
|
7.7%
14/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Nausea
|
7.7%
14/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Depression
|
7.2%
13/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Memory impairment
|
7.2%
13/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Toothache
|
7.2%
13/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Renal and urinary disorders
Urinary retention
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Ataxia
|
6.6%
12/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Injury, poisoning and procedural complications
Laceration
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
12/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Infections and infestations
Sinusitis
|
6.6%
12/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Amnesia
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Aphasia
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Eye disorders
Retinal pigmentation
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Ear and labyrinth disorders
Vertigo
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Eye disorders
Vision blurred
|
6.1%
11/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Eye disorders
Diplopia
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Nervous system disorders
Speech disorder
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Renal and urinary disorders
Urinary hesitation
|
5.5%
10/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
|
Psychiatric disorders
Confusional state
|
8.3%
15/181 • SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
SAEs and non-serious AEs were assessed in the Safety Population
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER