Trial Outcomes & Findings for Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia (NCT NCT01977482)
NCT ID: NCT01977482
Last Updated: 2018-06-08
Results Overview
Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
216 participants
Primary outcome timeframe
Baseline (Week -4, Week-2 and Day 1) and Week 4
Results posted on
2018-06-08
Participant Flow
Eligible participants were hemodialysis-dependent with anemia associated with chronic kidney disease who were switched from a stable dose of recombinant human erythropoietin (rhEPO).
A total of 216 participants with a stable hemoglobin (Hgb) between 9.0-11.5 grams (g)/deciliter (dL) (France sites only: 10.0-11.5 g/dL) were randomized.
Participant milestones
| Measure |
Control
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
40
|
39
|
40
|
19
|
|
Overall Study
COMPLETED
|
36
|
30
|
35
|
35
|
37
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
5
|
4
|
3
|
5
|
Reasons for withdrawal
| Measure |
Control
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other-Protocol-defined Stopping Criteria
|
0
|
3
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
3
|
1
|
5
|
Baseline Characteristics
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
Baseline characteristics by cohort
| Measure |
Control
n=39 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=39 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=40 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=39 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=40 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=19 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Years
|
59.7 Years
STANDARD_DEVIATION 18.74 • n=39 Participants
|
58.7 Years
STANDARD_DEVIATION 13.33 • n=41 Participants
|
63.5 Years
STANDARD_DEVIATION 14.00 • n=35 Participants
|
60.1 Years
STANDARD_DEVIATION 10.36 • n=31 Participants
|
55.4 Years
STANDARD_DEVIATION 15.50 • n=146 Participants
|
59.9 Years
STANDARD_DEVIATION 13.26 • n=19 Participants
|
59.5 Years
STANDARD_DEVIATION 14.58 • n=147 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
8 Participants
n=19 Participants
|
80 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
11 Participants
n=19 Participants
|
136 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
12 Participants
n=19 Participants
|
150 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
4 Participants
n=19 Participants
|
27 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
35 Participants
n=147 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
4 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week -4, Week-2 and Day 1) and Week 4Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.
Outcome measures
| Measure |
Control
n=39 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=39 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=40 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=39 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=40 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=19 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hgb) at Week 4
|
-0.64 grams (g)/deciliter (dL)
Standard Deviation 0.829
|
-0.24 grams (g)/deciliter (dL)
Standard Deviation 0.989
|
0.08 grams (g)/deciliter (dL)
Standard Deviation 1.131
|
0.42 grams (g)/deciliter (dL)
Standard Deviation 0.796
|
0.64 grams (g)/deciliter (dL)
Standard Deviation 1.177
|
0.61 grams (g)/deciliter (dL)
Standard Deviation 1.245
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Hgb values measured at Week 24 are presented.
Outcome measures
| Measure |
Control
n=24 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=18 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=27 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=26 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=24 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=11 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Hgb Concentration at Week 24
|
10.56 g/dL
Standard Deviation 0.974
|
10.29 g/dL
Standard Deviation 0.864
|
10.54 g/dL
Standard Deviation 1.010
|
10.63 g/dL
Standard Deviation 1.099
|
10.28 g/dL
Standard Deviation 0.856
|
10.70 g/dL
Standard Deviation 0.867
|
SECONDARY outcome
Timeframe: Week 20 to Week 24Population: ITT population. Only participants with data available at specific timepoint were analyzed.
The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.
Outcome measures
| Measure |
Control
n=31 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=22 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=28 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24
Percentage of time within target range
|
54.59 Percentage of days
Standard Deviation 42.044
|
74.77 Percentage of days
Standard Deviation 38.797
|
57.38 Percentage of days
Standard Deviation 40.505
|
37.46 Percentage of days
Standard Deviation 41.775
|
48.97 Percentage of days
Standard Deviation 42.490
|
55.23 Percentage of days
Standard Deviation 40.350
|
|
Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24
Percentage of time above target range
|
24.65 Percentage of days
Standard Deviation 38.556
|
6.89 Percentage of days
Standard Deviation 22.137
|
17.18 Percentage of days
Standard Deviation 30.446
|
33.15 Percentage of days
Standard Deviation 42.856
|
18.27 Percentage of days
Standard Deviation 33.698
|
26.88 Percentage of days
Standard Deviation 36.154
|
|
Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24
Percentage of time below target range
|
20.76 Percentage of days
Standard Deviation 36.587
|
18.34 Percentage of days
Standard Deviation 35.778
|
25.44 Percentage of days
Standard Deviation 40.120
|
29.39 Percentage of days
Standard Deviation 42.670
|
32.76 Percentage of days
Standard Deviation 43.780
|
17.89 Percentage of days
Standard Deviation 36.836
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.
Outcome measures
| Measure |
Control
n=24 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=18 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=27 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=26 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=24 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=11 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hgb in the Target Range at Week 24
|
14 Participants
|
13 Participants
|
16 Participants
|
10 Participants
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: ITT Population
The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL were presented.
Outcome measures
| Measure |
Control
n=39 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=38 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=39 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=38 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=39 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=17 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reaching Pre-defined Hgb Stopping Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: ITT Population. Only participants with data available at specific time point were analyzed.
Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.
Outcome measures
| Measure |
Control
n=36 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=37 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=37 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=37 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=36 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=16 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Change From Baseline in Erythropoietin (EPO)
|
1946.45 international units(IU)/Liter (L)
Standard Deviation 8456.313
|
48.86 international units(IU)/Liter (L)
Standard Deviation 117.050
|
36.63 international units(IU)/Liter (L)
Standard Deviation 35.485
|
84.53 international units(IU)/Liter (L)
Standard Deviation 225.768
|
82.00 international units(IU)/Liter (L)
Standard Deviation 99.660
|
24.63 international units(IU)/Liter (L)
Standard Deviation 235.820
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 28Population: ITT Population. Only participants with data available at specific time point were analyzed.
Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.
Outcome measures
| Measure |
Control
n=36 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=37 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=37 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=37 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=36 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=16 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)
|
36.02 Percent change
Interval 16.45 to 58.87
|
36.92 Percent change
Interval 19.33 to 57.11
|
41.73 Percent change
Interval 22.65 to 63.77
|
54.91 Percent change
Interval 37.38 to 74.69
|
50.65 Percent change
Interval 31.88 to 72.1
|
50.97 Percent change
Interval 21.49 to 87.6
|
SECONDARY outcome
Timeframe: Day 1, Week 4, and Week 20Population: Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population
Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose \[PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour \[hr\] post-dose \[PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.
Outcome measures
| Measure |
Control
n=39 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=40 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=39 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=40 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=19 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.58
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.49
|
2.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.99
|
2.2 nanograms (ng)/milliliter (mL)
Standard Deviation 1.38
|
2.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.42
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W20, PrD, n=23, 28, 27, 23, 14
|
1.5 nanograms (ng)/milliliter (mL)
Standard Deviation 2.31
|
1.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.03
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.93
|
1.6 nanograms (ng)/milliliter (mL)
Standard Deviation 3.80
|
1.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.67
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
1.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.89
|
1.0 nanograms (ng)/milliliter (mL)
Standard Deviation 1.34
|
1.6 nanograms (ng)/milliliter (mL)
Standard Deviation 1.81
|
2.0 nanograms (ng)/milliliter (mL)
Standard Deviation 3.58
|
1.0 nanograms (ng)/milliliter (mL)
Standard Deviation 1.45
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
2.3 nanograms (ng)/milliliter (mL)
Standard Deviation 2.04
|
2.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.22
|
3.3 nanograms (ng)/milliliter (mL)
Standard Deviation 2.89
|
3.8 nanograms (ng)/milliliter (mL)
Standard Deviation 3.10
|
2.8 nanograms (ng)/milliliter (mL)
Standard Deviation 2.34
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.02
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
9.9 nanograms (ng)/milliliter (mL)
Standard Deviation 8.00
|
14.7 nanograms (ng)/milliliter (mL)
Standard Deviation 10.02
|
22.2 nanograms (ng)/milliliter (mL)
Standard Deviation 14.71
|
24.5 nanograms (ng)/milliliter (mL)
Standard Deviation 18.27
|
29.1 nanograms (ng)/milliliter (mL)
Standard Deviation 24.55
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
5.4 nanograms (ng)/milliliter (mL)
Standard Deviation 4.49
|
7.1 nanograms (ng)/milliliter (mL)
Standard Deviation 5.53
|
11.8 nanograms (ng)/milliliter (mL)
Standard Deviation 8.49
|
13.1 nanograms (ng)/milliliter (mL)
Standard Deviation 9.50
|
17.3 nanograms (ng)/milliliter (mL)
Standard Deviation 16.03
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
4.0 nanograms (ng)/milliliter (mL)
Standard Deviation 3.63
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 3.50
|
8.1 nanograms (ng)/milliliter (mL)
Standard Deviation 5.74
|
9.0 nanograms (ng)/milliliter (mL)
Standard Deviation 7.05
|
10.1 nanograms (ng)/milliliter (mL)
Standard Deviation 10.61
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
4.9 nanograms (ng)/milliliter (mL)
Standard Deviation 5.56
|
3.8 nanograms (ng)/milliliter (mL)
Standard Deviation 4.88
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 4.71
|
6.2 nanograms (ng)/milliliter (mL)
Standard Deviation 8.65
|
4.0 nanograms (ng)/milliliter (mL)
Standard Deviation 4.80
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
3.3 nanograms (ng)/milliliter (mL)
Standard Deviation 3.36
|
3.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.35
|
5.9 nanograms (ng)/milliliter (mL)
Standard Deviation 4.66
|
6.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.90
|
8.7 nanograms (ng)/milliliter (mL)
Standard Deviation 8.72
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W20, PrD, n=23, 28, 27, 23, 14
|
7.7 nanograms (ng)/milliliter (mL)
Standard Deviation 7.71
|
7.3 nanograms (ng)/milliliter (mL)
Standard Deviation 7.34
|
7.9 nanograms (ng)/milliliter (mL)
Standard Deviation 7.37
|
9.3 nanograms (ng)/milliliter (mL)
Standard Deviation 10.95
|
7.2 nanograms (ng)/milliliter (mL)
Standard Deviation 10.04
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 4.07
|
3.6 nanograms (ng)/milliliter (mL)
Standard Deviation 4.55
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 4.64
|
5.5 nanograms (ng)/milliliter (mL)
Standard Deviation 5.38
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.28
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
11.4 nanograms (ng)/milliliter (mL)
Standard Deviation 7.47
|
17.0 nanograms (ng)/milliliter (mL)
Standard Deviation 9.89
|
23.1 nanograms (ng)/milliliter (mL)
Standard Deviation 15.22
|
25.4 nanograms (ng)/milliliter (mL)
Standard Deviation 14.25
|
28.8 nanograms (ng)/milliliter (mL)
Standard Deviation 21.46
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
6.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.84
|
8.6 nanograms (ng)/milliliter (mL)
Standard Deviation 6.43
|
13.1 nanograms (ng)/milliliter (mL)
Standard Deviation 9.73
|
13.9 nanograms (ng)/milliliter (mL)
Standard Deviation 7.66
|
17.4 nanograms (ng)/milliliter (mL)
Standard Deviation 14.72
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
4.7 nanograms (ng)/milliliter (mL)
Standard Deviation 4.23
|
5.7 nanograms (ng)/milliliter (mL)
Standard Deviation 4.63
|
9.3 nanograms (ng)/milliliter (mL)
Standard Deviation 7.37
|
9.6 nanograms (ng)/milliliter (mL)
Standard Deviation 5.50
|
9.9 nanograms (ng)/milliliter (mL)
Standard Deviation 9.05
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W20, PrD, n=23, 28, 27, 23, 14
|
7.8 nanograms (ng)/milliliter (mL)
Standard Deviation 8.53
|
6.0 nanograms (ng)/milliliter (mL)
Standard Deviation 8.08
|
6.7 nanograms (ng)/milliliter (mL)
Standard Deviation 6.74
|
7.8 nanograms (ng)/milliliter (mL)
Standard Deviation 11.14
|
6.2 nanograms (ng)/milliliter (mL)
Standard Deviation 8.78
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
5.7 nanograms (ng)/milliliter (mL)
Standard Deviation 5.43
|
4.7 nanograms (ng)/milliliter (mL)
Standard Deviation 4.91
|
6.8 nanograms (ng)/milliliter (mL)
Standard Deviation 6.54
|
8.5 nanograms (ng)/milliliter (mL)
Standard Deviation 10.83
|
5.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.58
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
5.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.52
|
5.1 nanograms (ng)/milliliter (mL)
Standard Deviation 5.18
|
7.4 nanograms (ng)/milliliter (mL)
Standard Deviation 6.43
|
8.4 nanograms (ng)/milliliter (mL)
Standard Deviation 6.86
|
6.5 nanograms (ng)/milliliter (mL)
Standard Deviation 5.14
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
6.3 nanograms (ng)/milliliter (mL)
Standard Deviation 10.04
|
9.3 nanograms (ng)/milliliter (mL)
Standard Deviation 19.06
|
7.7 nanograms (ng)/milliliter (mL)
Standard Deviation 18.46
|
25.4 nanograms (ng)/milliliter (mL)
Standard Deviation 53.37
|
9.0 nanograms (ng)/milliliter (mL)
Standard Deviation 18.80
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
10.6 nanograms (ng)/milliliter (mL)
Standard Deviation 25.15
|
16.3 nanograms (ng)/milliliter (mL)
Standard Deviation 57.24
|
8.7 nanograms (ng)/milliliter (mL)
Standard Deviation 19.85
|
19.9 nanograms (ng)/milliliter (mL)
Standard Deviation 42.65
|
8.0 nanograms (ng)/milliliter (mL)
Standard Deviation 16.92
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
7.5 nanograms (ng)/milliliter (mL)
Standard Deviation 16.80
|
8.1 nanograms (ng)/milliliter (mL)
Standard Deviation 23.76
|
5.6 nanograms (ng)/milliliter (mL)
Standard Deviation 11.75
|
12.7 nanograms (ng)/milliliter (mL)
Standard Deviation 28.60
|
4.6 nanograms (ng)/milliliter (mL)
Standard Deviation 6.87
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
6.8 nanograms (ng)/milliliter (mL)
Standard Deviation 14.53
|
4.6 nanograms (ng)/milliliter (mL)
Standard Deviation 10.49
|
4.4 nanograms (ng)/milliliter (mL)
Standard Deviation 9.19
|
11.3 nanograms (ng)/milliliter (mL)
Standard Deviation 25.36
|
11.2 nanograms (ng)/milliliter (mL)
Standard Deviation 33.59
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W20, PrD, n=23, 28, 27, 23, 14
|
2.3 nanograms (ng)/milliliter (mL)
Standard Deviation 6.44
|
0.7 nanograms (ng)/milliliter (mL)
Standard Deviation 2.55
|
0.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.82
|
7.9 nanograms (ng)/milliliter (mL)
Standard Deviation 30.99
|
6.6 nanograms (ng)/milliliter (mL)
Standard Deviation 20.22
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
25.9 nanograms (ng)/milliliter (mL)
Standard Deviation 35.74
|
37.6 nanograms (ng)/milliliter (mL)
Standard Deviation 53.77
|
88.2 nanograms (ng)/milliliter (mL)
Standard Deviation 153.06
|
58.5 nanograms (ng)/milliliter (mL)
Standard Deviation 85.91
|
65.2 nanograms (ng)/milliliter (mL)
Standard Deviation 127.21
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
34.2 nanograms (ng)/milliliter (mL)
Standard Deviation 31.76
|
52.4 nanograms (ng)/milliliter (mL)
Standard Deviation 53.32
|
62.8 nanograms (ng)/milliliter (mL)
Standard Deviation 85.37
|
82.7 nanograms (ng)/milliliter (mL)
Standard Deviation 117.97
|
63.3 nanograms (ng)/milliliter (mL)
Standard Deviation 102.15
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK1278863, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
43.6 nanograms (ng)/milliliter (mL)
Standard Deviation 58.36
|
39.2 nanograms (ng)/milliliter (mL)
Standard Deviation 44.59
|
44.1 nanograms (ng)/milliliter (mL)
Standard Deviation 70.53
|
71.2 nanograms (ng)/milliliter (mL)
Standard Deviation 110.91
|
65.8 nanograms (ng)/milliliter (mL)
Standard Deviation 100.80
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
9.1 nanograms (ng)/milliliter (mL)
Standard Deviation 6.68
|
12.9 nanograms (ng)/milliliter (mL)
Standard Deviation 8.32
|
18.5 nanograms (ng)/milliliter (mL)
Standard Deviation 13.72
|
20.1 nanograms (ng)/milliliter (mL)
Standard Deviation 12.32
|
21.3 nanograms (ng)/milliliter (mL)
Standard Deviation 17.34
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
5.1 nanograms (ng)/milliliter (mL)
Standard Deviation 4.22
|
6.7 nanograms (ng)/milliliter (mL)
Standard Deviation 5.51
|
10.3 nanograms (ng)/milliliter (mL)
Standard Deviation 8.55
|
10.9 nanograms (ng)/milliliter (mL)
Standard Deviation 6.37
|
13.1 nanograms (ng)/milliliter (mL)
Standard Deviation 12.44
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
3.8 nanograms (ng)/milliliter (mL)
Standard Deviation 3.66
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.16
|
7.4 nanograms (ng)/milliliter (mL)
Standard Deviation 6.44
|
7.4 nanograms (ng)/milliliter (mL)
Standard Deviation 4.51
|
7.2 nanograms (ng)/milliliter (mL)
Standard Deviation 6.97
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
3.3 nanograms (ng)/milliliter (mL)
Standard Deviation 3.76
|
3.3 nanograms (ng)/milliliter (mL)
Standard Deviation 3.15
|
5.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.86
|
5.4 nanograms (ng)/milliliter (mL)
Standard Deviation 3.63
|
6.6 nanograms (ng)/milliliter (mL)
Standard Deviation 5.72
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W20, PrD, n=23, 28, 27, 23, 14
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 7.72
|
3.2 nanograms (ng)/milliliter (mL)
Standard Deviation 4.97
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 5.84
|
4.6 nanograms (ng)/milliliter (mL)
Standard Deviation 9.29
|
3.5 nanograms (ng)/milliliter (mL)
Standard Deviation 6.69
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
3.9 nanograms (ng)/milliliter (mL)
Standard Deviation 5.59
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 3.60
|
4.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.90
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 8.10
|
2.6 nanograms (ng)/milliliter (mL)
Standard Deviation 3.64
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
5.4 nanograms (ng)/milliliter (mL)
Standard Deviation 5.58
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.96
|
6.5 nanograms (ng)/milliliter (mL)
Standard Deviation 6.93
|
8.1 nanograms (ng)/milliliter (mL)
Standard Deviation 10.33
|
4.9 nanograms (ng)/milliliter (mL)
Standard Deviation 4.08
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2391220, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
5.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.64
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 5.26
|
7.3 nanograms (ng)/milliliter (mL)
Standard Deviation 6.69
|
8.2 nanograms (ng)/milliliter (mL)
Standard Deviation 6.52
|
6.1 nanograms (ng)/milliliter (mL)
Standard Deviation 4.92
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
3.1 nanograms (ng)/milliliter (mL)
Standard Deviation 2.82
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 4.47
|
5.7 nanograms (ng)/milliliter (mL)
Standard Deviation 6.31
|
7.2 nanograms (ng)/milliliter (mL)
Standard Deviation 6.57
|
5.2 nanograms (ng)/milliliter (mL)
Standard Deviation 4.66
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
1.8 nanograms (ng)/milliliter (mL)
Standard Deviation 1.75
|
2.6 nanograms (ng)/milliliter (mL)
Standard Deviation 3.81
|
3.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.55
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 3.73
|
3.7 nanograms (ng)/milliliter (mL)
Standard Deviation 4.61
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
1.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.67
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 3.21
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 3.58
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 2.44
|
1.7 nanograms (ng)/milliliter (mL)
Standard Deviation 1.68
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.88
|
1.5 nanograms (ng)/milliliter (mL)
Standard Deviation 2.46
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.85
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 1.92
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.21
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W20, PrD, n=23, 28, 27, 23, 14
|
1.2 nanograms (ng)/milliliter (mL)
Standard Deviation 3.38
|
0.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.05
|
0.7 nanograms (ng)/milliliter (mL)
Standard Deviation 1.28
|
1.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.09
|
0.7 nanograms (ng)/milliliter (mL)
Standard Deviation 1.84
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
2.0 nanograms (ng)/milliliter (mL)
Standard Deviation 3.82
|
1.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.73
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 3.97
|
3.4 nanograms (ng)/milliliter (mL)
Standard Deviation 5.88
|
1.0 nanograms (ng)/milliliter (mL)
Standard Deviation 1.34
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
3.8 nanograms (ng)/milliliter (mL)
Standard Deviation 4.58
|
3.6 nanograms (ng)/milliliter (mL)
Standard Deviation 4.36
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 5.82
|
6.3 nanograms (ng)/milliliter (mL)
Standard Deviation 8.04
|
3.7 nanograms (ng)/milliliter (mL)
Standard Deviation 3.28
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2487818, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
3.9 nanograms (ng)/milliliter (mL)
Standard Deviation 3.49
|
4.3 nanograms (ng)/milliliter (mL)
Standard Deviation 4.76
|
5.7 nanograms (ng)/milliliter (mL)
Standard Deviation 5.28
|
6.5 nanograms (ng)/milliliter (mL)
Standard Deviation 5.05
|
5.0 nanograms (ng)/milliliter (mL)
Standard Deviation 4.43
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
3.2 nanograms (ng)/milliliter (mL)
Standard Deviation 1.98
|
4.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.68
|
6.6 nanograms (ng)/milliliter (mL)
Standard Deviation 4.16
|
7.6 nanograms (ng)/milliliter (mL)
Standard Deviation 4.30
|
9.0 nanograms (ng)/milliliter (mL)
Standard Deviation 6.19
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
1.8 nanograms (ng)/milliliter (mL)
Standard Deviation 1.31
|
2.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.71
|
3.7 nanograms (ng)/milliliter (mL)
Standard Deviation 2.60
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 2.15
|
5.4 nanograms (ng)/milliliter (mL)
Standard Deviation 4.10
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
1.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.07
|
1.6 nanograms (ng)/milliliter (mL)
Standard Deviation 1.16
|
2.6 nanograms (ng)/milliliter (mL)
Standard Deviation 1.94
|
2.9 nanograms (ng)/milliliter (mL)
Standard Deviation 1.68
|
2.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.24
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
1.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.16
|
1.2 nanograms (ng)/milliliter (mL)
Standard Deviation 0.88
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 1.52
|
2.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.23
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 2.04
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W20, PrD, n=23, 28, 27, 23, 14
|
2.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.99
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.05
|
2.3 nanograms (ng)/milliliter (mL)
Standard Deviation 2.09
|
2.6 nanograms (ng)/milliliter (mL)
Standard Deviation 2.87
|
2.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.87
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.27
|
1.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.40
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.22
|
1.8 nanograms (ng)/milliliter (mL)
Standard Deviation 2.12
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.57
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
1.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.25
|
1.2 nanograms (ng)/milliliter (mL)
Standard Deviation 1.24
|
1.8 nanograms (ng)/milliliter (mL)
Standard Deviation 1.72
|
2.2 nanograms (ng)/milliliter (mL)
Standard Deviation 2.53
|
1.6 nanograms (ng)/milliliter (mL)
Standard Deviation 1.37
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2506102, W20, 3 hr PoD, n=23, 27, 27, 24, 14
|
1.4 nanograms (ng)/milliliter (mL)
Standard Deviation 1.12
|
1.3 nanograms (ng)/milliliter (mL)
Standard Deviation 1.26
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 1.53
|
2.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.66
|
1.7 nanograms (ng)/milliliter (mL)
Standard Deviation 1.42
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, D1, PrD, n=39, 40, 39, 40, 18
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
0.0 nanograms (ng)/milliliter (mL)
Standard Deviation 0.00
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W4, 6-12 hr PoD, n=36, 37, 37, 35, 15
|
3.4 nanograms (ng)/milliliter (mL)
Standard Deviation 2.46
|
4.9 nanograms (ng)/milliliter (mL)
Standard Deviation 3.11
|
6.9 nanograms (ng)/milliliter (mL)
Standard Deviation 4.52
|
8.0 nanograms (ng)/milliliter (mL)
Standard Deviation 4.87
|
7.9 nanograms (ng)/milliliter (mL)
Standard Deviation 5.75
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W4, 7-13 hr PoD, n=36, 37, 35, 35, 15
|
2.0 nanograms (ng)/milliliter (mL)
Standard Deviation 1.72
|
2.7 nanograms (ng)/milliliter (mL)
Standard Deviation 2.41
|
4.0 nanograms (ng)/milliliter (mL)
Standard Deviation 2.97
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 2.70
|
4.9 nanograms (ng)/milliliter (mL)
Standard Deviation 4.05
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W4, 8-14 hr PoD, n=35, 37, 36, 35, 15
|
1.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.46
|
1.8 nanograms (ng)/milliliter (mL)
Standard Deviation 1.86
|
2.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.30
|
3.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.95
|
2.5 nanograms (ng)/milliliter (mL)
Standard Deviation 1.78
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531398, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
2.1 nanograms (ng)/milliliter (mL)
Standard Deviation 2.24
|
1.9 nanograms (ng)/milliliter (mL)
Standard Deviation 2.09
|
2.9 nanograms (ng)/milliliter (mL)
Standard Deviation 3.28
|
3.5 nanograms (ng)/milliliter (mL)
Standard Deviation 4.69
|
2.1 nanograms (ng)/milliliter (mL)
Standard Deviation 1.79
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W20, 1 hr PoD, n=23, 27, 27, 24, 13
|
4.2 nanograms (ng)/milliliter (mL)
Standard Deviation 4.52
|
4.0 nanograms (ng)/milliliter (mL)
Standard Deviation 6.77
|
4.7 nanograms (ng)/milliliter (mL)
Standard Deviation 4.18
|
5.6 nanograms (ng)/milliliter (mL)
Standard Deviation 7.48
|
4.5 nanograms (ng)/milliliter (mL)
Standard Deviation 5.44
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531401, W20, 2 hr PoD, n=23, 27, 27, 24, 13
|
4.2 nanograms (ng)/milliliter (mL)
Standard Deviation 4.44
|
3.6 nanograms (ng)/milliliter (mL)
Standard Deviation 4.50
|
4.8 nanograms (ng)/milliliter (mL)
Standard Deviation 4.08
|
6.1 nanograms (ng)/milliliter (mL)
Standard Deviation 8.21
|
4.4 nanograms (ng)/milliliter (mL)
Standard Deviation 4.41
|
—
|
|
Population Plasma PK Parameters of GSK1278863 and Metabolites
GSK2531403, W4, 9-15 hr PoD, n=35, 36, 36, 35, 15
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 4.60
|
4.1 nanograms (ng)/milliliter (mL)
Standard Deviation 3.41
|
6.7 nanograms (ng)/milliliter (mL)
Standard Deviation 5.50
|
6.9 nanograms (ng)/milliliter (mL)
Standard Deviation 4.25
|
8.9 nanograms (ng)/milliliter (mL)
Standard Deviation 7.79
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.
Outcome measures
| Measure |
Control
n=32 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=26 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Hepcidin at Week 24
|
3.63 Percent change
Interval -20.39 to 34.89
|
-17.39 Percent change
Interval -42.36 to 18.4
|
-11.85 Percent change
Interval -26.47 to 5.67
|
-30.28 Percent change
Interval -48.08 to -6.37
|
-6.91 Percent change
Interval -28.69 to 21.52
|
-42.13 Percent change
Interval -62.82 to -9.95
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=33 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Ferritin at Week 24
|
56.8 Micrograms/Liter
Standard Deviation 214.27
|
-29.4 Micrograms/Liter
Standard Deviation 357.10
|
-50.4 Micrograms/Liter
Standard Deviation 408.99
|
-95.6 Micrograms/Liter
Standard Deviation 304.61
|
-20.2 Micrograms/Liter
Standard Deviation 227.34
|
-125.2 Micrograms/Liter
Standard Deviation 354.64
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=33 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Transferrin at Week 24
|
-0.133 grams (g)/Liter (L)
Standard Deviation 0.2903
|
0.238 grams (g)/Liter (L)
Standard Deviation 0.3709
|
0.198 grams (g)/Liter (L)
Standard Deviation 0.2891
|
0.226 grams (g)/Liter (L)
Standard Deviation 0.2706
|
0.249 grams (g)/Liter (L)
Standard Deviation 0.3213
|
0.393 grams (g)/Liter (L)
Standard Deviation 0.3165
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100\*(exp(Mean change log scale)-1).
Outcome measures
| Measure |
Control
n=32 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Transferrin Saturation at Week 24
|
-9.0 Percent change
Interval -27.3 to 13.9
|
-3.7 Percent change
Interval -22.9 to 20.4
|
-12.1 Percent change
Interval -23.4 to 0.9
|
-8.3 Percent change
Interval -22.9 to 9.0
|
8.2 Percent change
Interval -7.7 to 26.8
|
-2.5 Percent change
Interval -16.0 to 13.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=33 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Iron at Week 24
|
-0.8 Micromoles/Liter
Standard Deviation 7.64
|
0.9 Micromoles/Liter
Standard Deviation 9.75
|
0.3 Micromoles/Liter
Standard Deviation 5.20
|
0.2 Micromoles/Liter
Standard Deviation 6.51
|
2.0 Micromoles/Liter
Standard Deviation 3.96
|
1.6 Micromoles/Liter
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=32 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=27 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=25 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=14 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Total Iron Binding Capacity at Week 24
|
-2.0 Micromoles/Liter
Standard Deviation 4.48
|
6.0 Micromoles/Liter
Standard Deviation 7.93
|
4.2 Micromoles/Liter
Standard Deviation 6.79
|
6.6 Micromoles/Liter
Standard Deviation 5.75
|
4.8 Micromoles/Liter
Standard Deviation 6.25
|
6.2 Micromoles/Liter
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=30 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=26 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=24 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=12 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Hemoglobin at Week 24
|
-0.19 Picogram
Standard Deviation 1.610
|
-0.28 Picogram
Standard Deviation 1.948
|
-0.62 Picogram
Standard Deviation 2.046
|
-0.42 Picogram
Standard Deviation 1.458
|
-0.51 Picogram
Standard Deviation 1.377
|
-0.63 Picogram
Standard Deviation 1.119
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=30 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=28 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=26 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=13 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hematocrit at Week 24
|
-0.0028 Ratio
Standard Deviation 0.04358
|
-0.0096 Ratio
Standard Deviation 0.04073
|
0.0020 Ratio
Standard Deviation 0.03579
|
0.0043 Ratio
Standard Deviation 0.04254
|
-0.0021 Ratio
Standard Deviation 0.02678
|
0.0108 Ratio
Standard Deviation 0.03557
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=30 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=29 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=28 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=26 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=13 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Red Blood Cells at Week 24
|
0.01 10^12 cells/Liter
Standard Deviation 0.460
|
-0.06 10^12 cells/Liter
Standard Deviation 0.396
|
0.04 10^12 cells/Liter
Standard Deviation 0.374
|
0.07 10^12 cells/Liter
Standard Deviation 0.399
|
0.03 10^12 cells/Liter
Standard Deviation 0.300
|
0.17 10^12 cells/Liter
Standard Deviation 0.366
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: ITT Population. Only participants with data available at specific time point were analyzed.
A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.
Outcome measures
| Measure |
Control
n=31 Participants
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=20 Participants
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=30 Participants
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=28 Participants
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=26 Participants
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=12 Participants
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Reticulocyte Count at Week 24
|
0.40 Percentage of reticulocytes in blood
Standard Deviation 0.663
|
0.16 Percentage of reticulocytes in blood
Standard Deviation 1.162
|
0.18 Percentage of reticulocytes in blood
Standard Deviation 0.571
|
0.03 Percentage of reticulocytes in blood
Standard Deviation 0.684
|
-0.15 Percentage of reticulocytes in blood
Standard Deviation 0.838
|
0.10 Percentage of reticulocytes in blood
Standard Deviation 0.527
|
Adverse Events
Control
Serious events: 11 serious events
Other events: 17 other events
Deaths: 0 deaths
GSK1278863 4 mg
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
GSK1278863 6 mg
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
GSK1278863 8 mg
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
GSK1278863 10 mg
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
GSK1278863 12 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=39 participants at risk
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=39 participants at risk
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=40 participants at risk
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=39 participants at risk
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=40 participants at risk
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=19 participants at risk
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sick sinus syndrome
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Uterine inflammation
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Steal syndrome
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Superior vena cava stenosis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Control
n=39 participants at risk
Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 4 mg
n=39 participants at risk
Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 6 mg
n=40 participants at risk
Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 8 mg
n=39 participants at risk
Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 10 mg
n=40 participants at risk
Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
GSK1278863 12 mg
n=19 participants at risk
Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
12.8%
5/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
17.9%
7/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
15.4%
6/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
5/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
12.8%
5/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
15.0%
6/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.5%
3/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.3%
1/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.3%
4/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
7.7%
3/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.5%
1/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
15.4%
6/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
10.0%
4/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
2.6%
1/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.1%
2/39 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
5.0%
2/40 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
0.00%
0/19 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and until the follow up contact (up to 28 weeks).
Post baseline SAEs and non-serious AEs were reported for the Safety population which consisted of all participants who received at least one dose of study drug.
|
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