Trial Outcomes & Findings for A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity (NCT NCT01205451)
NCT ID: NCT01205451
Last Updated: 2017-02-28
Results Overview
The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
109 participants
Primary outcome timeframe
Baseline (Day 0), Week 6, and Week 12
Results posted on
2017-02-28
Participant Flow
Study LOC114609 (NCT01205451) is the open-label (OL) extension of Study 112958 (a double-blind \[DB\] study; NCT01153815). Within 3 months of completion of Study 112958, eligible participants were enrolled in Study 114609.
Participant milestones
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
|
Overall Study
COMPLETED
|
47
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
Baseline Characteristics
A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 Years
STANDARD_DEVIATION 10.90 • n=39 Participants
|
55.4 Years
STANDARD_DEVIATION 12.53 • n=41 Participants
|
54.9 Years
STANDARD_DEVIATION 11.70 • n=35 Participants
|
|
Gender
Female
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Gender
Male
|
43 Participants
n=39 Participants
|
43 Participants
n=41 Participants
|
86 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
53 participants
n=39 Participants
|
53 participants
n=41 Participants
|
106 participants
n=35 Participants
|
|
Number of participants with the absence or presence of thumb spasticity
Absence
|
6 participants
n=39 Participants
|
6 participants
n=41 Participants
|
12 participants
n=35 Participants
|
|
Number of participants with the absence or presence of thumb spasticity
Presence
|
47 participants
n=39 Participants
|
47 participants
n=41 Participants
|
94 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.
The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
Week 6
|
-1.21 scores on a scale
Standard Deviation 0.616
|
-1.33 scores on a scale
Standard Deviation 0.753
|
|
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
Week 12
|
-0.88 scores on a scale
Standard Deviation 0.589
|
-1.12 scores on a scale
Standard Deviation 0.752
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension).
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
Week 6
|
43 participants
|
42 participants
|
|
Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
Week 12
|
35 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 6
|
-1.14 scores on a scale
Standard Deviation 0.716
|
-1.29 scores on a scale
Standard Deviation 0.769
|
|
Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS
Week 12
|
-0.72 scores on a scale
Standard Deviation 0.607
|
-0.96 scores on a scale
Standard Deviation 0.805
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.
The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ \[regarded as 1.5\], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part\[s\] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 6
|
-1.02 scores on a scale
Standard Deviation 0.642
|
-1.22 scores on a scale
Standard Deviation 0.721
|
|
Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS
Week 12
|
-0.80 scores on a scale
Standard Deviation 0.631
|
-0.92 scores on a scale
Standard Deviation 0.716
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Week 6, and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 6
|
-0.64 scores on a scale
Standard Deviation 0.591
|
-0.72 scores on a scale
Standard Deviation 0.662
|
|
Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)
Week 12
|
-0.59 scores on a scale
Standard Deviation 0.570
|
-0.57 scores on a scale
Standard Deviation 0.665
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
Week 6
|
1.9 scores on a scale
Standard Deviation 0.91
|
2.2 scores on a scale
Standard Deviation 0.84
|
|
Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
Week 12
|
1.6 scores on a scale
Standard Deviation 0.82
|
1.9 scores on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Week 6 and Week 12Population: FAS Population. The missing data imputation method was used for analysis.
The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=53 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
Week 6
|
1.8 scores on a scale
Standard Deviation 0.91
|
2.1 scores on a scale
Standard Deviation 0.85
|
|
GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
Week 12
|
1.6 scores on a scale
Standard Deviation 0.81
|
1.7 scores on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and exit visit (Week 12 or earlier)Population: Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit
|
-0.050 10^12 cells per Liter
Standard Deviation 0.3682
|
-0.039 10^12 cells per Liter
Standard Deviation 0.3087
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit
WBCs
|
0.111 10^9 cells per Liter
Standard Deviation 1.3340
|
-0.273 10^9 cells per Liter
Standard Deviation 2.1714
|
|
Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit
Platelets
|
-10.660 10^9 cells per Liter
Standard Deviation 38.8734
|
-1.386 10^9 cells per Liter
Standard Deviation 41.5828
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Basophils
|
0.032 Percentage of the total WBC
Standard Deviation 0.2920
|
0.010 Percentage of the total WBC
Standard Deviation 0.2185
|
|
Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Neutrophils
|
-0.009 Percentage of the total WBC
Standard Deviation 6.3905
|
-0.757 Percentage of the total WBC
Standard Deviation 7.8585
|
|
Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Lymphocytes
|
0.118 Percentage of the total WBC
Standard Deviation 6.4613
|
0.734 Percentage of the total WBC
Standard Deviation 6.7396
|
|
Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Monocytes
|
-0.217 Percentage of the total WBC
Standard Deviation 1.6570
|
0.55 Percentage of the total WBC
Standard Deviation 2.7845
|
|
Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit
Eosinophils
|
0.094 Percentage of the total WBC
Standard Deviation 1.3067
|
0.49 Percentage of the total WBC
Standard Deviation 2.3799
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Hemoglobin Content at the Exit Visit
|
-0.255 Grams per Liter (grams/L)
Standard Deviation 10.9989
|
-1.409 Grams per Liter (grams/L)
Standard Deviation 8.7559
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Hematocrit Value at the Exit Visit
|
-0.003 percentage
Standard Deviation 0.0254
|
-0.007 percentage
Standard Deviation 0.0257
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit
Total Protein
|
-0.711 grams/L
Standard Deviation 5.8908
|
-1.484 grams/L
Standard Deviation 6.0077
|
|
Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit
Albumin
|
-0.400 grams/L
Standard Deviation 3.5067
|
-0.236 grams/L
Standard Deviation 4.4753
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit
ALT, n=47, 44
|
-1.100 International Units per Liter (IU/L)
Standard Deviation 10.9938
|
-0.005 International Units per Liter (IU/L)
Standard Deviation 13.6079
|
|
Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit
AST, n=47, 44
|
-0.153 International Units per Liter (IU/L)
Standard Deviation 9.3633
|
-0.302 International Units per Liter (IU/L)
Standard Deviation 8.2277
|
|
Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit
y-GT, n=47, 44
|
-1.098 International Units per Liter (IU/L)
Standard Deviation 14.0099
|
0.316 International Units per Liter (IU/L)
Standard Deviation 17.4397
|
|
Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit
ALP, n=46, 44
|
-3.087 International Units per Liter (IU/L)
Standard Deviation 10.4821
|
-4.225 International Units per Liter (IU/L)
Standard Deviation 17.2055
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit
Creatinine
|
-1.509 Micromoles per Liter (μmol/L)
Standard Deviation 9.8783
|
-0.984 Micromoles per Liter (μmol/L)
Standard Deviation 20.1303
|
|
Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit
Uric Acid
|
-3.670 Micromoles per Liter (μmol/L)
Standard Deviation 61.1350
|
-16.198 Micromoles per Liter (μmol/L)
Standard Deviation 67.7636
|
|
Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit
Total Bilirubin
|
0.249 Micromoles per Liter (μmol/L)
Standard Deviation 4.6873
|
-0.293 Micromoles per Liter (μmol/L)
Standard Deviation 3.6399
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
BUN, n=47, 44
|
-0.292 Millimoles per Liter (mmol/L)
Standard Deviation 1.1855
|
0.226 Millimoles per Liter (mmol/L)
Standard Deviation 2.9929
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
FBG, n=47, 43
|
0.209 Millimoles per Liter (mmol/L)
Standard Deviation 1.3513
|
-0.081 Millimoles per Liter (mmol/L)
Standard Deviation 0.8000
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Sodium, n=47, 44
|
0.423 Millimoles per Liter (mmol/L)
Standard Deviation 3.5990
|
-0.034 Millimoles per Liter (mmol/L)
Standard Deviation 2.7857
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Potassium, n=47, 44
|
-0.008 Millimoles per Liter (mmol/L)
Standard Deviation 0.4014
|
-0.060 Millimoles per Liter (mmol/L)
Standard Deviation 0.5128
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Chloride, n=47, 44
|
1.077 Millimoles per Liter (mmol/L)
Standard Deviation 4.0509
|
-0.143 Millimoles per Liter (mmol/L)
Standard Deviation 3.4336
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Total cholesterol, n=47, 43
|
-0.057 Millimoles per Liter (mmol/L)
Standard Deviation 0.8410
|
0.282 Millimoles per Liter (mmol/L)
Standard Deviation 0.9535
|
|
Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit
Triglycerides, n=47, 43
|
-0.039 Millimoles per Liter (mmol/L)
Standard Deviation 0.6525
|
0.119 Millimoles per Liter (mmol/L)
Standard Deviation 0.5698
|
SECONDARY outcome
Timeframe: Screening visit (-Week 1) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.
Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator's clinical judgment; no specific criteria were used.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=44 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urine protein, Screening
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urine protein, Exit visit
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Blood, Screening
|
0 participants
|
3 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Blood, Exit visit
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Leukocytes, Screening
|
1 participants
|
3 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Leukocytes, Exit visit
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urine glucose, Screeing
|
2 participants
|
3 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urine glucose, Exit visit
|
0 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urobilinogen, Screening
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
Urobilinogen, Exit visit
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=46 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit
Systolic BP
|
-3.1 Millimeters of mercury (mmHg)
Standard Deviation 8.96
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 10.02
|
|
Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit
Diastolic BP
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 6.27
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Baseline (Screening) and the exit visit (Week 12 or earlier)Population: Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.
The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Outcome measures
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=47 Participants
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=46 Participants
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Mean Change From Baseline in Pulse Rate at the Exit Visit
|
-3.0 beats per minute
Standard Deviation 9.27
|
1.0 beats per minute
Standard Deviation 8.49
|
Adverse Events
BOTOX in Original DB Study; BOTOX in OL Study
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo in Original DB Study; BOTOX in OL Study
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 participants at risk
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=56 participants at risk
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cerebral arteriovenous malformation haemorrhagic
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
Other adverse events
| Measure |
BOTOX in Original DB Study; BOTOX in OL Study
n=53 participants at risk
Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
Placebo in Original DB Study; BOTOX in OL Study
n=56 participants at risk
Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters \[mL\]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.8%
2/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
5.4%
3/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Blood bilirubin increased
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Blood glucose increased
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Blood potassium increased
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Protein total decreased
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
1.8%
1/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
|
Nervous system disorders
Epilepsy
|
1.9%
1/53 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
0.00%
0/56 • Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.
Serious and non-serious adverse events were collected in members of the Safety Set Population, which included all of the enrolled and treated participants.
|
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