Trial Outcomes & Findings for Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) (NCT NCT00540423)
NCT ID: NCT00540423
Last Updated: 2011-03-30
Results Overview
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Week 6
Results posted on
2011-03-30
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
|
SB-497115-GR, Double-blind
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR, Open-label
All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
|
|---|---|---|---|
|
Double-Blind Treatment Period
STARTED
|
8
|
15
|
0
|
|
Double-Blind Treatment Period
COMPLETED
|
8
|
14
|
0
|
|
Double-Blind Treatment Period
NOT COMPLETED
|
0
|
1
|
0
|
|
Open-Label Treatment Period
STARTED
|
0
|
0
|
22
|
|
Open-Label Treatment Period
COMPLETED
|
0
|
0
|
20
|
|
Open-Label Treatment Period
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
|
SB-497115-GR, Double-blind
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR, Open-label
All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
|
|---|---|---|---|
|
Double-Blind Treatment Period
Adverse Event
|
0
|
1
|
0
|
|
Open-Label Treatment Period
Lack of Efficacy
|
0
|
0
|
2
|
Baseline Characteristics
Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Baseline characteristics by cohort
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.7 years
STANDARD_DEVIATION 13.72 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 11.72 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese Heritage
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Number of Responders at Week 6
Responders
|
9 Participants
|
0 Participants
|
—
|
|
Number of Responders at Week 6
Non-responders
|
6 Participants
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 26Population: Full Analysis Set
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders
|
43.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2 through 6Population: Full Analysis Set
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter) at at least 4 out of 5 scheduled visits.
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6
Responders
|
5 Participants
|
0 Participants
|
—
|
|
Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6
Non-responders
|
9 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22, 29, 36, and 43Population: Full Analysis Set
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Responders at Each Visit
Day 8
|
6.7 Percentage of responders
|
0 Percentage of responders
|
—
|
|
Percentage of Responders at Each Visit
Day 15
|
26.7 Percentage of responders
|
0 Percentage of responders
|
—
|
|
Percentage of Responders at Each Visit
Day 22
|
33.3 Percentage of responders
|
0 Percentage of responders
|
—
|
|
Percentage of Responders at Each Visit
Day 29
|
60.0 Percentage of responders
|
0 Percentage of responders
|
—
|
|
Percentage of Responders at Each Visit
Day 36
|
66.7 Percentage of responders
|
0 Percentage of responders
|
—
|
|
Percentage of Responders at Each Visit
Day 43
|
60.0 Percentage of responders
|
0 Percentage of responders
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 8, 15, 22, 29, 36, and 43Population: Full Analysis Set
Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Platelet Count at Each Visit
Baseline
|
19.3 10^9/Liter
Standard Deviation 6.79
|
12.6 10^9/Liter
Standard Deviation 8.65
|
—
|
|
Mean Platelet Count at Each Visit
Day 8
|
26.9 10^9/Liter
Standard Deviation 17.77
|
14.3 10^9/Liter
Standard Deviation 12.26
|
—
|
|
Mean Platelet Count at Each Visit
Day 15
|
54.9 10^9/Liter
Standard Deviation 55.84
|
13.5 10^9/Liter
Standard Deviation 12.15
|
—
|
|
Mean Platelet Count at Each Visit
Day 22
|
54.4 10^9/Liter
Standard Deviation 46.88
|
11.6 10^9/Liter
Standard Deviation 9.50
|
—
|
|
Mean Platelet Count at Each Visit
Day 29
|
73.3 10^9/Liter
Standard Deviation 46.72
|
10.6 10^9/Liter
Standard Deviation 9.04
|
—
|
|
Mean Platelet Count at Each Visit
Day 36
|
99.4 10^9/Liter
Standard Deviation 78.62
|
11.9 10^9/Liter
Standard Deviation 10.79
|
—
|
|
Mean Platelet Count at Each Visit
Day 43
|
95.1 10^9/Liter
Standard Deviation 100.25
|
9.9 10^9/Liter
Standard Deviation 4.76
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 8, 15, 22, 29, 36, and 43Population: Full Analysis Set
Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value
Outcome measures
| Measure |
SB-497115-GR
n=8 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=15 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 8
|
1.6 10^9/Liter
Standard Deviation 6.05
|
7.6 10^9/Liter
Standard Deviation 16.47
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 15
|
0.9 10^9/Liter
Standard Deviation 5.46
|
35.5 10^9/Liter
Standard Deviation 56.11
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 22
|
-1.0 10^9/Liter
Standard Deviation 3.02
|
35.0 10^9/Liter
Standard Deviation 46.52
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 29
|
-2.0 10^9/Liter
Standard Deviation 4.17
|
53.9 10^9/Liter
Standard Deviation 46.02
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 36
|
-0.8 10^9/Liter
Standard Deviation 7.94
|
80.1 10^9/Liter
Standard Deviation 77.06
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 43
|
-2.8 10^9/Liter
Standard Deviation 9.41
|
75.8 10^9/Liter
Standard Deviation 99.93
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 29, 36, and 43Population: Full Analysis Set
When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 1
|
33 Percentage of participants
|
75 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 8
|
13 Percentage of participants
|
63 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 15
|
14 Percentage of participants
|
63 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 22
|
29 Percentage of participants
|
75 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 29
|
0 Percentage of participants
|
38 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 36
|
7 Percentage of participants
|
63 Percentage of participants
|
—
|
|
Percentage of Participants With Bleeding Episodes Since the Last Visit
Day 43
|
14 Percentage of participants
|
75 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 8, 15, 22, 29, 36, and 43Population: Full Analysis Set
Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
Outcome measures
| Measure |
SB-497115-GR
n=15 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=8 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, Platelet counts (PC) <=15 x 10^9/L
|
3 Participants
|
6 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, PC >15 to <30 x 10^9/L
|
12 Participants
|
2 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, PC >=30 to <=50 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, PC =>50 to <=200 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, PC >200 to <=400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Baseline, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC <=15 x 10^9/L
|
3 Participants
|
5 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC >15 to <30 x 10^9/L
|
6 Participants
|
2 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC >=30 to <=50 x 10^9/L
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC =>50 to <=200 x 10^9/L
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC >200 to <=400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 8, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC <=15 x 10^9/L
|
2 Participants
|
6 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC >15 to <30 x 10^9/L
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC >=30 to <=50 x 10^9/L
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC =>50 to <=200 x 10^9/L
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC >200 to <=400 x 10^9/L
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 15, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC <=15 x 10^9/L
|
3 Participants
|
5 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC >15 to <30 x 10^9/L
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC >=30 to <=50 x 10^9/L
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC =>50 to <=200 x 10^9/L
|
5 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC >200 to <=400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 22, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC <=15 x 10^9/L
|
1 Participants
|
6 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC >15 to <30 x 10^9/L
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC >=30 to <=50 x 10^9/L
|
4 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC =>50 to <=200 x 10^9/L
|
9 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC >200 to <=400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 29, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC <=15 x 10^9/L
|
2 Participants
|
7 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC >15 to <30 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC >=30 to <=50 x 10^9/L
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC =>50 to <=200 x 10^9/L
|
9 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC >200 to <=400 x 10^9/L
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 36, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC <=15 x 10^9/L
|
2 Participants
|
7 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC >15 to <30 x 10^9/L
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC >=30 to <=50 x 10^9/L
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC =>50 to <=200 x 10^9/L
|
7 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC >200 to <=400 x 10^9/L
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category
Day 43, PC >400 x 10^9/L
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26Population: Full Analysis Set
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Responders at Each Visit
Day 8
|
4.3 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Day 15
|
17.4 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Day 22
|
21.7 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Day 29
|
47.8 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Day 36
|
56.5 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Day 43
|
52.2 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Week 10
|
57.1 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Week 14
|
60.9 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Week 18
|
50.0 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Week 22
|
52.4 Percentage of responders
|
—
|
—
|
|
Percentage of Responders at Each Visit
Week 26
|
69.6 Percentage of responders
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26Population: Full Analysis Set
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Platelet Counts of Participants at Each Visit
Baseline
|
16.5 10^9/Liter
Standard Deviation 8.45
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 8
|
23.0 10^9/Liter
Standard Deviation 16.77
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 15
|
41.5 10^9/Liter
Standard Deviation 48.32
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 22
|
41.0 10^9/Liter
Standard Deviation 41.80
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 29
|
55.3 10^9/Liter
Standard Deviation 45.75
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 36
|
78.1 10^9/Liter
Standard Deviation 72.76
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Day 43
|
78.0 10^9/Liter
Standard Deviation 88.31
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Week 10
|
88.9 10^9/Liter
Standard Deviation 81.15
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Week 14
|
121.6 10^9/Liter
Standard Deviation 121.20
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Week 18
|
87.3 10^9/Liter
Standard Deviation 80.09
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Week 22
|
78.5 10^9/Liter
Standard Deviation 57.58
|
—
|
—
|
|
Mean Platelet Counts of Participants at Each Visit
Week 26
|
86.2 10^9/Liter
Standard Deviation 49.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26Population: Full Analysis Set
Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 8
|
6.4 10^9/Liter
Standard Deviation 13.53
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 15
|
25.1 10^9/Liter
Standard Deviation 46.73
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 22
|
24.6 10^9/Liter
Standard Deviation 39.37
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 29
|
38.9 10^9/Liter
Standard Deviation 42.37
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 36
|
61.7 10^9/Liter
Standard Deviation 69.53
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Day 43
|
61.6 10^9/Liter
Standard Deviation 86.72
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Week 10
|
71.4 10^9/Liter
Standard Deviation 80.01
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Week 14
|
104.5 10^9/Liter
Standard Deviation 120.20
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Week 18
|
69.4 10^9/Liter
Standard Deviation 80.23
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Week 22
|
61.1 10^9/Liter
Standard Deviation 54.85
|
—
|
—
|
|
Mean Change From Baseline in Platelet Counts at Each Visit
Week 26
|
68.4 10^9/Liter
Standard Deviation 46.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 through 26Population: Full Analysis Set
Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter
|
59.5 Days
Standard Deviation 46.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 through 26Population: Full Analysis Set
Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter
|
78.4 Days
Standard Deviation 54.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26Population: Full Analysis Set
When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 1
|
48 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 8
|
35 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 15
|
27 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 22
|
36 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 29
|
18 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 36
|
23 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Day 43
|
27 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Week 10
|
11 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Week 14
|
14 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Week 18
|
26 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Week 22
|
28 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Bleeding Episode Since the Last Visit
Week 26
|
5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline.
ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=19 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline
|
36.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 through 26Population: Full Analysis Set
Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Percentage of Participants Who Received Rescue Treatment for ITP
|
9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1 through 26Population: Full Analysis Set
Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Outcome measures
| Measure |
SB-497115-GR
n=23 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Mean Number of Days of Concomitant ITP Medication Use Per Month
|
25.14 Days
Standard Deviation 11.796
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment
Cmax: Peak plasma concentration of SB-497115
Outcome measures
| Measure |
SB-497115-GR
n=8 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, Cmax
|
2992.4 ng/mL (nanograms/milliliter)
Standard Deviation 1253.14
|
6776.4 ng/mL (nanograms/milliliter)
Standard Deviation 2619.62
|
11877.8 ng/mL (nanograms/milliliter)
Standard Deviation 3926.21
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population
tmax: Time when Cmax was achieved
Outcome measures
| Measure |
SB-497115-GR
n=8 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, Tmax
|
3.192 Hours
Interval 2.0 to 4.17
|
4.000 Hours
Interval 2.0 to 4.0
|
2.967 Hours
Interval 1.92 to 4.17
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.
t1/2 is half life based on the terminal phase
Outcome measures
| Measure |
SB-497115-GR
n=7 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115, t1/2
|
19.50 Hours
Standard Deviation 7.164
|
29.96 Hours
Standard Deviation 7.664
|
18.19 Hours
Standard Deviation 4.938
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.
Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve.
Outcome measures
| Measure |
SB-497115-GR
n=7 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, Lambda z
|
0.04021 1/hour
Standard Deviation 0.015558
|
0.02724 1/hour
Standard Deviation 0.006881
|
0.04040 1/hour
Standard Deviation 0.011422
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.
AUC is area under a concentration vs. time curve. AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation: AUC0-24= AUClast + Clast × (1 - e-λz × \[24-tlast\])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation.
Outcome measures
| Measure |
SB-497115-GR
n=7 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24
AUClast
|
41671.5 hr*ng/mL
Standard Deviation 24344.64
|
92556.2 hr*ng/mL
Standard Deviation 41095.63
|
171523.2 hr*ng/mL
Standard Deviation 75250.93
|
|
Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24
AUC0-24
|
41637.2 hr*ng/mL
Standard Deviation 24361.51
|
92527.5 hr*ng/mL
Standard Deviation 41122.30
|
171551.0 hr*ng/mL
Standard Deviation 75242.59
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.
CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed.
Outcome measures
| Measure |
SB-497115-GR
n=7 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, CL/F
|
0.37156 L/hr (Liters/hour)
Standard Deviation 0.154284
|
0.30923 L/hr (Liters/hour)
Standard Deviation 0.114096
|
0.33035 L/hr (Liters/hour)
Standard Deviation 0.124401
|
SECONDARY outcome
Timeframe: Week 9 or 10Population: PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.
VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed.
Outcome measures
| Measure |
SB-497115-GR
n=7 Participants
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
Placebo
n=5 Participants
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR 50 mg
n=4 Participants
Participants who received 50 mg of SB-497115-GR on the PK sampling day
|
|---|---|---|---|
|
Pharmacokinetics of SB-497115-GR, Vz/F
|
5.6267 Liters
Standard Deviation 2.00964
|
5.3870 Liters
Standard Deviation 1.75077
|
5.0391 Liters
Standard Deviation 1.76091
|
Adverse Events
Placebo Short-Term (Double-Blind) Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SB-497115-GR Short-Term (Double-Blind) Phase
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
SB-497115-GR Long-Term Phase
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Short-Term (Double-Blind) Phase
n=8 participants at risk
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR Short-Term (Double-Blind) Phase
n=15 participants at risk
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR Long-Term Phase
n=23 participants at risk
All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhagic diathesis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
4.3%
1/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
4.3%
1/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
4.3%
1/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
4.3%
1/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
Other adverse events
| Measure |
Placebo Short-Term (Double-Blind) Phase
n=8 participants at risk
Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR Short-Term (Double-Blind) Phase
n=15 participants at risk
SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
|
SB-497115-GR Long-Term Phase
n=23 participants at risk
All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
26.7%
4/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
43.5%
10/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
20.0%
3/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
17.4%
4/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
13.0%
3/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
13.0%
3/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Blood and lymphatic system disorders
Platelet count increased
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
General disorders
Fatigue
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
8.7%
2/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Eye disorders
Cataract
|
12.5%
1/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Investigations
Blood creatine phosphokinase decresed
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Renal and urinary disorders
Cystitis-like symptom
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
|
Renal and urinary disorders
Dysmenorrhoea
|
0.00%
0/8 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
6.7%
1/15 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
0.00%
0/23 • AE data were collected from the beginning of the double-blind (DB) phase. In the Long-Term (LT) phase, AEs were pooled from all participants (pts) who started the DB phase, regardless of whether they completed the phase.
Participants (pts) taking placebo in the DB phase took SB-497115-GR (drug) in the OL phase for up to 26 weeks (wks). Pts receiving drug in the DB phase for 7 wks continued to receive it in the OL phase for 19 wks. Data from the 2 groups were pooled as a 26-wk treatment of drug for analysis. Thus, 23 pts were at risk in the Long-Term Phase.
|
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