Trial Outcomes & Findings for Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia (NCT NCT02791763)
NCT ID: NCT02791763
Last Updated: 2021-05-18
Results Overview
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
Weeks 40 to 52
Results posted on
2021-05-18
Participant Flow
This was an open-label, active-controlled, parallel-group, multi-center study to compare the efficacy (verification of non-inferiority) and safety of GSK1278863 (daprodustat) versus epoetin beta pegol in Japanese non-dialysis (ND) participants, including an open-label non-comparative cohort of peritoneal dialysis (PD) participants.
A total of 56 centers, contracted in Japan, enrolled and randomized participants. A total of 455 participants were screened and 355 participants were enrolled and randomized in this study.
Participant milestones
| Measure |
Daprodustat in ND Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat in PD Participants
Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
149
|
150
|
56
|
|
Overall Study
COMPLETED
|
111
|
113
|
43
|
|
Overall Study
NOT COMPLETED
|
38
|
37
|
13
|
Reasons for withdrawal
| Measure |
Daprodustat in ND Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat in PD Participants
Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Needs maintenance/changes in dialysis
|
16
|
19
|
5
|
|
Overall Study
Cancer event
|
1
|
3
|
0
|
|
Overall Study
Participant had renal transplant
|
3
|
0
|
0
|
|
Overall Study
Met hemoglobin stopping criteria
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
12
|
13
|
7
|
Baseline Characteristics
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
Baseline characteristics by cohort
| Measure |
Daprodustat in ND Participants
n=149 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=150 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat in PD Participants
n=56 Participants
Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.2 Years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
70.3 Years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
68.5 Years
STANDARD_DEVIATION 10.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian- Japanese Heritage
|
149 Count of Participants
n=5 Participants
|
150 Count of Participants
n=7 Participants
|
56 Count of Participants
n=5 Participants
|
355 Count of Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Weeks 40 to 52Population: Intent to treat (ITT) Population comprised of cohort 1 participants (only erythropoiesis stimulating agent \[ESA\] users) and cohort 3 participants (both ESA users and ESA non-users) who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
|
11.97 Grams per deciliter (g/dL)
Standard Error 0.061
|
11.86 Grams per deciliter (g/dL)
Standard Error 0.063
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: Modified intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the efficacy evaluation period.
ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
Responder
|
81 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
Non-Responder
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: mITT Population
The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
Responder
|
92 Percentage of participants
|
92 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
Non-Responder
|
8 Percentage of participants
|
8 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hgb at Week 4 in ND Participants
|
0.47 g/dL
Standard Deviation 0.878
|
0.26 g/dL
Standard Deviation 0.711
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: Efficacy peritoneal dialysis (PD) Population comprised of PD participants who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hgb at Week 4 in PD Participants
|
-0.09 g/dL
Standard Deviation 0.899
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
<=-2.0
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
>-2.0 and <=-1.0
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
>-1.0 and <=0
|
28 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
>0 and <=1.0
|
43 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
>1.0 and <=2.0
|
29 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
>2.0
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
within +/- 1.0
|
72 Participants
|
90 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants by Hgb Change From Baseline Category at Week 4
over +/- 2.0
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
<=-2.0
|
1 Percentage of participants
|
2 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
>-2.0 and <=-1.0
|
4 Percentage of participants
|
3 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
>-1.0 and <=0
|
26 Percentage of participants
|
30 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
>0 and <=1.0
|
40 Percentage of participants
|
51 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
>1.0 and <=2.0
|
27 Percentage of participants
|
14 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
>2.0
|
2 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
within +/- 1.0
|
67 Percentage of participants
|
83 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants by Hgb Change From Baseline Category at Week 4
over +/- 2.0
|
3 Percentage of participants
|
1 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: Efficacy PD Population
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
<=-2.0
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
>-2.0 and <=-1.0
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
>-1.0 and <=0
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
>0 and <=1.0
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
>1.0 and <=2.0
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
>2.0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
within +/- 1.0
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants by Hgb Change From Baseline Category at Week 4
over +/- 2.0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: Efficacy PD Population
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to \<=-2.0, \>-2.0 and \<=-1.0, \>-1.0 and \<=0, \>0 and \<=1.0, \>1.0 and \<=2.0, \>2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
>-1.0 and <=0
|
36 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
<=-2.0
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
>-2.0 and <=-1.0
|
18 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
>0 and <=1.0
|
36 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
>1.0 and <=2.0
|
7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
>2.0
|
2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
within +/- 1.0
|
75 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants by Hgb Change From Baseline Category at Week 4
over +/- 2.0
|
2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Daprodustat Dose Level by Visit in ND Participants
Week 16, n=103
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Day 1, n=108
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 4, n=106
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 8, n=106
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 12, n=106
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 20, n=100
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 24, n=96
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 28, n=94
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 32, n=92
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 36, n=89
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 40, n=88
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 44, n=88
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in ND Participants
Week 48, n=87
|
4.0 Milligrams per day (mg/day)
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks. Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=109 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Day 1, n=109
|
50.0 Micrograms per 4 weeks
Interval 50.0 to 50.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 4, n=109
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 8, n=107
|
100.0 Micrograms per 4 weeks
Interval 50.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 12, n=105
|
100.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 16, n=104
|
75.0 Micrograms per 4 weeks
Interval 25.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 20, n=100
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 24, n=97
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 28, n=92
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 32, n=90
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 36, n=88
|
75.0 Micrograms per 4 weeks
Interval 75.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 40, n=87
|
75.0 Micrograms per 4 weeks
Interval 50.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 44, n=84
|
100.0 Micrograms per 4 weeks
Interval 62.5 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Epoetin Beta Pegol Dose Level by Visit in ND Participants
Week 48, n=82
|
100.0 Micrograms per 4 weeks
Interval 75.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Daprodustat Dose Level by Visit in PD Participants
Day 1, n=55
|
4.0 mg/day
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 4, n=55
|
6.0 mg/day
Interval 4.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 8, n=52
|
6.0 mg/day
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 12, n=52
|
6.0 mg/day
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 16, n=51
|
6.0 mg/day
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 20, n=50
|
6.0 mg/day
Interval 4.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 24, n=48
|
8.0 mg/day
Interval 4.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 28, n=45
|
8.0 mg/day
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 32, n=45
|
6.0 mg/day
Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 36, n=45
|
8.0 mg/day
Interval 4.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 40, n=44
|
6.0 mg/day
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 44, n=43
|
6.0 mg/day
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Daprodustat Dose Level by Visit in PD Participants
Week 48, n=43
|
6.0 mg/day
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis.
The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=42 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=39 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants
|
28.0 Days
Interval 14.0 to 111.0
|
28.0 Days
Interval 26.0 to 113.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Efficacy PD Population. Only those participants who had Hgb \> 13.0 g/dL of Hemocue were included in analysis.
The duration (in days) of treatment interruption due to Hgb \>13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb \>13 g/dL.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=23 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants
|
28.0 Days
Interval 19.0 to 168.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Number of dose adjustments in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Dose Adjustments in ND Participants
|
5.0 Number of dose adjustments
Interval 0.0 to 9.0
|
6.0 Number of dose adjustments
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Efficacy PD Population
Number of dose adjustments in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Dose Adjustments in PD Participants
|
5.0 Number of dose adjustments
Interval 0.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Hgb values at each assessment visit for ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Hgb Values at Each Assessment Visit in ND Participants
Day 1, n=108,109
|
10.48 g/dL
Standard Deviation 1.140
|
10.68 g/dL
Standard Deviation 1.066
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 4, n=107,109
|
10.95 g/dL
Standard Deviation 1.122
|
10.94 g/dL
Standard Deviation 1.024
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 8, n=107,109
|
11.19 g/dL
Standard Deviation 1.092
|
11.34 g/dL
Standard Deviation 0.905
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 12, n=106,107
|
11.51 g/dL
Standard Deviation 1.024
|
11.84 g/dL
Standard Deviation 0.880
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 16, n=104,105
|
11.90 g/dL
Standard Deviation 1.091
|
12.07 g/dL
Standard Deviation 1.073
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 20, n=102,103
|
11.84 g/dL
Standard Deviation 0.909
|
11.96 g/dL
Standard Deviation 0.820
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 24, n=99,99
|
11.87 g/dL
Standard Deviation 0.740
|
11.80 g/dL
Standard Deviation 0.855
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 28, n=96,93
|
11.98 g/dL
Standard Deviation 0.845
|
11.83 g/dL
Standard Deviation 0.859
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 32, n=92,90
|
12.03 g/dL
Standard Deviation 0.785
|
11.80 g/dL
Standard Deviation 0.875
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 36, n=92,88
|
11.93 g/dL
Standard Deviation 0.730
|
11.81 g/dL
Standard Deviation 0.810
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 40, n=88,87
|
11.88 g/dL
Standard Deviation 0.735
|
12.00 g/dL
Standard Deviation 0.857
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 44, n=88,86
|
11.87 g/dL
Standard Deviation 0.868
|
11.75 g/dL
Standard Deviation 0.763
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 48, n=87,83
|
12.05 g/dL
Standard Deviation 0.896
|
11.80 g/dL
Standard Deviation 0.904
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in ND Participants
Week 52, n=87,81
|
12.01 g/dL
Standard Deviation 1.003
|
11.99 g/dL
Standard Deviation 0.930
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Hgb values at each assessment visit for PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Hgb Values at Each Assessment Visit in PD Participants
Day 1, n=55
|
10.85 g/dL
Standard Deviation 0.964
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 4, n=55
|
10.77 g/dL
Standard Deviation 1.239
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 8, n=54
|
10.83 g/dL
Standard Deviation 1.259
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 12, n=52
|
11.36 g/dL
Standard Deviation 1.097
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 16, n=51
|
11.42 g/dL
Standard Deviation 1.079
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 20, n=50
|
11.54 g/dL
Standard Deviation 0.807
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 24, n=49
|
11.69 g/dL
Standard Deviation 0.816
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 28, n=48
|
11.95 g/dL
Standard Deviation 1.038
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 32, n=45
|
12.07 g/dL
Standard Deviation 0.890
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 36, n=45
|
11.90 g/dL
Standard Deviation 0.839
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 40, n=44
|
12.12 g/dL
Standard Deviation 0.795
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 44, n=43
|
11.92 g/dL
Standard Deviation 0.824
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 48, n=43
|
12.10 g/dL
Standard Deviation 0.774
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hgb Values at Each Assessment Visit in PD Participants
Week 52, n=43
|
12.12 g/dL
Standard Deviation 0.699
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 48, n=87,83
|
1.61 g/dL
Standard Deviation 1.350
|
1.03 g/dL
Standard Deviation 1.172
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 4, n=107,109
|
0.47 g/dL
Standard Deviation 0.878
|
0.26 g/dL
Standard Deviation 0.711
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 8, n=107,109
|
0.71 g/dL
Standard Deviation 1.122
|
0.66 g/dL
Standard Deviation 1.109
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 12, n=106,107
|
1.04 g/dL
Standard Deviation 1.352
|
1.18 g/dL
Standard Deviation 1.384
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 16, n=104,105
|
1.45 g/dL
Standard Deviation 1.376
|
1.40 g/dL
Standard Deviation 1.495
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 20, n=102,103
|
1.39 g/dL
Standard Deviation 1.330
|
1.26 g/dL
Standard Deviation 1.336
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 24, n=99,99
|
1.41 g/dL
Standard Deviation 1.346
|
1.10 g/dL
Standard Deviation 1.295
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 28, n=96,93
|
1.54 g/dL
Standard Deviation 1.375
|
1.08 g/dL
Standard Deviation 1.151
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 32, n=92,90
|
1.60 g/dL
Standard Deviation 1.371
|
1.04 g/dL
Standard Deviation 1.299
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 36, n=92,88
|
1.49 g/dL
Standard Deviation 1.265
|
1.04 g/dL
Standard Deviation 1.294
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 40, n=88,87
|
1.44 g/dL
Standard Deviation 1.371
|
1.26 g/dL
Standard Deviation 1.304
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 44, n=88,86
|
1.43 g/dL
Standard Deviation 1.435
|
1.01 g/dL
Standard Deviation 1.131
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants
Week 52, n=87,81
|
1.56 g/dL
Standard Deviation 1.527
|
1.21 g/dL
Standard Deviation 1.432
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 4, n=55
|
-0.09 g/dL
Standard Deviation 0.899
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 8, n=54
|
-0.06 g/dL
Standard Deviation 1.127
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 12, n=52
|
0.44 g/dL
Standard Deviation 1.173
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 16, n=51
|
0.52 g/dL
Standard Deviation 1.295
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 20, n=50
|
0.63 g/dL
Standard Deviation 1.158
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 24, n=49
|
0.74 g/dL
Standard Deviation 1.182
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 28, n=48
|
1.00 g/dL
Standard Deviation 1.317
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 32, n=45
|
1.13 g/dL
Standard Deviation 1.192
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 36, n=45
|
0.95 g/dL
Standard Deviation 1.106
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 40, n=44
|
1.13 g/dL
Standard Deviation 1.227
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 44, n=43
|
0.90 g/dL
Standard Deviation 1.093
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 48, n=43
|
1.08 g/dL
Standard Deviation 1.248
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants
Week 52, n=43
|
1.10 g/dL
Standard Deviation 1.226
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Day 1, n=108,109
|
29 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 4, n=107,109
|
43 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 8, n=107,109
|
64 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 12, n=106,107
|
78 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 16, n=104,105
|
84 Participants
|
80 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 20, n=102,103
|
88 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 24, n=99,99
|
86 Participants
|
85 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 28, n=96,93
|
77 Participants
|
73 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 32, n=92,90
|
79 Participants
|
67 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 36, n=92,88
|
79 Participants
|
70 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 40, n=88,87
|
78 Participants
|
72 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 44, n=88,86
|
71 Participants
|
68 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 48, n=87,83
|
75 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 52, n=87,81
|
67 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Day 1, n=108,109
|
27 Percentage of Participants
|
33 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 4, n=107,109
|
40 Percentage of Participants
|
44 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 8, n=107,109
|
60 Percentage of Participants
|
67 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 12, n=106,107
|
74 Percentage of Participants
|
79 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 16, n=104,105
|
81 Percentage of Participants
|
76 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 20, n=102,103
|
86 Percentage of Participants
|
83 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 24, n=99,99
|
87 Percentage of Participants
|
86 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 28, n=96,93
|
80 Percentage of Participants
|
78 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 32, n=92,90
|
86 Percentage of Participants
|
74 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 36, n=92,88
|
86 Percentage of Participants
|
80 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 40, n=88,87
|
89 Percentage of Participants
|
83 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 44, n=88,86
|
81 Percentage of Participants
|
79 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 48, n=87,83
|
86 Percentage of Participants
|
75 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 52, n=87,81
|
77 Percentage of Participants
|
73 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 32, n=45
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 36, n=45
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 40, n=44
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 44, n=43
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 48, n=43
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 52, n=43
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Day 1, n=55
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 4, n=55
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 8, n=54
|
26 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 12, n=52
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 16, n=51
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 20, n=50
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 24, n=49
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 28, n=48
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Day 1, n=55
|
51 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 4, n=55
|
45 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 8, n=54
|
48 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 12, n=52
|
62 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 16, n=51
|
63 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 20, n=50
|
76 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 24, n=49
|
73 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 28, n=48
|
81 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 32, n=45
|
76 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 36, n=45
|
80 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 40, n=44
|
77 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 44, n=43
|
77 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 48, n=43
|
84 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit
Week 52, n=43
|
88 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants
|
85.44 Percentage of time
Standard Deviation 22.473
|
80.57 Percentage of time
Standard Deviation 25.973
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).
Outcome measures
| Measure |
Daprodustat in ND Participants
n=44 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants
|
85.73 Percentage of time
Standard Deviation 19.974
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population. Only those participants who experienced this event were included in analysis.
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=76 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=75 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants
|
58.0 Days
Interval 29.0 to 87.0
|
57.0 Days
Interval 29.0 to 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population. Only those participants who experienced this event were included in analysis.
The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb \>= 11.0 g/dL were excluded in this summary.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=27 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants
|
84.0 Days
Interval 29.0 to 141.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL
|
1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
|
17 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
|
16 Percentage of participants
|
10 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks
|
20 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
|
49 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL
|
45 Percentage of participants
|
48 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL
|
51 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants
|
76 Episodes
|
88 Episodes
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants
|
43 Episodes
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants
|
837.37 Milligrams
Standard Deviation 1209.100
|
747.04 Milligrams
Standard Deviation 1130.767
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Efficacy PD Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants
|
2468.68 Milligrams
Standard Deviation 5418.767
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants
|
967.41 Milligrams
Standard Deviation 1854.896
|
777.69 Milligrams
Standard Deviation 1639.331
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=44 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants
|
3038.67 Milligrams
Standard Deviation 6239.034
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the treatment period were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Used Oral Iron During the Treatment Period
|
56 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the treatment period were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Used Oral Iron During the Treatment Period
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: ITT Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the treatment period were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=108 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Used Oral Iron During the Treatment Period
|
52 Percentage of participants
|
45 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to week 52Population: Efficacy PD Population
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the treatment period were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Used Oral Iron During the Treatment Period
|
60 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
|
34 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=44 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=88 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=87 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
|
39 Percentage of participants
|
32 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 40 to 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.
Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=44 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period
|
50 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in Ferritin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ferritin in ND Participants
Week 4, n=107,109
|
-41.4 Micrograms per liter (µg/L)
Interval -53.7 to -29.2
|
-29.0 Micrograms per liter (µg/L)
Interval -41.1 to -16.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in ND Participants
Week 16, n=104,105
|
-83.4 Micrograms per liter (µg/L)
Interval -102.8 to -64.0
|
-29.3 Micrograms per liter (µg/L)
Interval -48.6 to -10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in ND Participants
Week 28, n=96,93
|
-80.1 Micrograms per liter (µg/L)
Interval -96.4 to -63.8
|
-16.6 Micrograms per liter (µg/L)
Interval -33.1 to -0.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in ND Participants
Week 40, n=88,87
|
-56.3 Micrograms per liter (µg/L)
Interval -79.1 to -33.4
|
-16.0 Micrograms per liter (µg/L)
Interval -38.9 to 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in ND Participants
Week 52, n=87,81
|
-42.7 Micrograms per liter (µg/L)
Interval -68.9 to -16.4
|
-14.0 Micrograms per liter (µg/L)
Interval -40.9 to 13.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in Ferritin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Ferritin in PD Participants
Week 4, n=55
|
-36.4 µg/L
Interval -49.8 to -23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in PD Participants
Week 16, n=51
|
-81.8 µg/L
Interval -103.7 to -59.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in PD Participants
Week 28, n=48
|
-89.1 µg/L
Interval -111.6 to -66.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in PD Participants
Week 40, n=44
|
-74.6 µg/L
Interval -112.7 to -36.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Ferritin in PD Participants
Week 52, n=43
|
-63.6 µg/L
Interval -101.0 to -26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Week 4, n=107,109
|
-12.4 Percent change
Interval -17.6 to -6.8
|
-5.4 Percent change
Interval -11.1 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Week 16, n=104,105
|
-16.3 Percent change
Interval -21.6 to -10.6
|
-0.3 Percent change
Interval -6.6 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Week 28, n=96,93
|
-17.5 Percent change
Interval -23.2 to -11.4
|
10.6 Percent change
Interval 2.9 to 18.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Week 40, n=88,87
|
-11.2 Percent change
Interval -17.8 to -4.1
|
12.5 Percent change
Interval 4.1 to 21.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants
Week 52, n=87,81
|
-11.7 Percent change
Interval -18.3 to -4.6
|
7.0 Percent change
Interval -1.3 to 15.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in TSAT in PD Participants
Week 4, n=55
|
-19.2 Percent change
Interval -27.2 to -10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in TSAT in PD Participants
Week 16, n=51
|
-29.1 Percent change
Interval -36.9 to -20.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in TSAT in PD Participants
Week 28, n=48
|
-22.6 Percent change
Interval -30.4 to -14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in TSAT in PD Participants
Week 40, n=44
|
-19.5 Percent change
Interval -28.3 to -9.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in TSAT in PD Participants
Week 52, n=43
|
-14.7 Percent change
Interval -25.4 to -2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=99 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=100 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Hepcidin in ND Participants
Week 4, n=99,100
|
-49.13 Percent change
Interval -54.63 to -42.97
|
-19.20 Percent change
Interval -27.82 to -9.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in ND Participants
Week 16, n=86,99
|
-55.67 Percent change
Interval -61.6 to -48.82
|
-3.73 Percent change
Interval -15.95 to 10.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in ND Participants
Week 28, n=81,85
|
-56.67 Percent change
Interval -62.53 to -49.9
|
7.61 Percent change
Interval -6.75 to 24.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in ND Participants
Week 40, n=76,80
|
-47.77 Percent change
Interval -55.1 to -39.23
|
9.54 Percent change
Interval -5.62 to 27.12
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in ND Participants
Week 52, n=76,74
|
-45.27 Percent change
Interval -54.32 to -34.43
|
10.13 Percent change
Interval -8.27 to 32.21
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100\*(exponential \[mean change on log scale\]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=53 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Hepcidin in PD Participants
Week 4, n=53
|
-49.79 Percent change
Interval -58.57 to -39.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in PD Participants
Week 16, n=48
|
-62.59 Percent change
Interval -69.95 to -53.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in PD Participants
Week 28, n=39
|
-65.37 Percent change
Interval -72.61 to -56.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in PD Participants
Week 40, n=39
|
-67.91 Percent change
Interval -76.1 to -56.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Hepcidin in PD Participants
Week 52, n=40
|
-54.77 Percent change
Interval -66.82 to -38.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in serum iron in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Iron in ND Participants
Week 4, n=107,109
|
0.5 Micromoles per liter (µmol/L)
Interval -0.6 to 1.5
|
-0.8 Micromoles per liter (µmol/L)
Interval -1.8 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in ND Participants
Week 16, n=104,105
|
0.3 Micromoles per liter (µmol/L)
Interval -0.8 to 1.3
|
0.6 Micromoles per liter (µmol/L)
Interval -0.4 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in ND Participants
Week 28, n=96,93
|
0.3 Micromoles per liter (µmol/L)
Interval -0.8 to 1.5
|
2.0 Micromoles per liter (µmol/L)
Interval 0.8 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in ND Participants
Week 40, n=88,87
|
0.9 Micromoles per liter (µmol/L)
Interval -0.2 to 2.1
|
1.8 Micromoles per liter (µmol/L)
Interval 0.6 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in ND Participants
Week 52, n=87,81
|
0.7 Micromoles per liter (µmol/L)
Interval -0.4 to 1.8
|
1.1 Micromoles per liter (µmol/L)
Interval -0.1 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in serum iron in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Iron in PD Participants
Week 4, n=55
|
-1.2 µmol/L
Interval -2.7 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in PD Participants
Week 16, n=51
|
-2.4 µmol/L
Interval -3.8 to -1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in PD Participants
Week 28, n=48
|
-1.0 µmol/L
Interval -2.5 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in PD Participants
Week 40, n=44
|
-0.4 µmol/L
Interval -1.9 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Serum Iron in PD Participants
Week 52, n=43
|
1.0 µmol/L
Interval -1.9 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in TIBC in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=107 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=109 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Week 4, n=107,109
|
6.9 µmol/L
Interval 6.2 to 7.7
|
0.5 µmol/L
Interval -0.2 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Week 16, n=104,105
|
9.9 µmol/L
Interval 8.7 to 11.0
|
1.9 µmol/L
Interval 0.8 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Week 28, n=96,93
|
9.9 µmol/L
Interval 8.7 to 11.1
|
1.4 µmol/L
Interval 0.2 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Week 40, n=88,87
|
8.0 µmol/L
Interval 6.6 to 9.4
|
0.2 µmol/L
Interval -1.2 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants
Week 52, n=87,81
|
7.8 µmol/L
Interval 6.3 to 9.3
|
0.1 µmol/L
Interval -1.4 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52Population: Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Change from Baseline in TIBC in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=55 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in TIBC in PD Participants
Week 4, n=55
|
6.9 µmol/L
Interval 5.7 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TIBC in PD Participants
Week 16, n=51
|
9.5 µmol/L
Interval 7.7 to 11.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TIBC in PD Participants
Week 28, n=48
|
11.0 µmol/L
Interval 8.8 to 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TIBC in PD Participants
Week 40, n=44
|
11.0 µmol/L
Interval 8.0 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in TIBC in PD Participants
Week 52, n=43
|
9.6 µmol/L
Interval 6.8 to 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24Population: PK Population comprised of all Daprodustat-treated participants from whom PK samples were collected and analyzed. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated timepoints. Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method. AUC (0-4) is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=13 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=68 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
n=113 Participants
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
n=83 Participants
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
n=66 Participants
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
n=16 Participants
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
n=7 Participants
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
n=1 Participants
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants
|
35.3199 Hour*nanogram per milliliter
Geometric Coefficient of Variation 38.4
|
63.0175 Hour*nanogram per milliliter
Geometric Coefficient of Variation 89.8
|
101.9293 Hour*nanogram per milliliter
Geometric Coefficient of Variation 96.5
|
152.4966 Hour*nanogram per milliliter
Geometric Coefficient of Variation 83.2
|
167.6515 Hour*nanogram per milliliter
Geometric Coefficient of Variation 105.9
|
190.0962 Hour*nanogram per milliliter
Geometric Coefficient of Variation 65.9
|
435.6847 Hour*nanogram per milliliter
Geometric Coefficient of Variation 131.7
|
404.0567 Hour*nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
SECONDARY outcome
Timeframe: 1, 2, 3 and 4 hours post dose at Weeks 12 and 24Population: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated timepoints. PK parameters of Daprodustat were calculated using non-compartmental method. Cmax is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
Outcome measures
| Measure |
Daprodustat in ND Participants
n=13 Participants
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=68 Participants
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat 4 mg
n=113 Participants
Participants received oral daprodustat tablet (4 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 6 mg
n=83 Participants
Participants received oral daprodustat tablet (6 mg) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 8 mg
n=66 Participants
Participants received oral dose of 8 mg daprodustat (4 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 12 mg
n=16 Participants
Participants received oral dose of 12 mg of daprodustat (6 mg\*2 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 18 mg
n=7 Participants
Participants received oral dose of 18 mg of daprodustat (6 mg\*3 tablets) once on the day of PK sampling at Week 12 or 24.
|
Daprodustat 24 mg
n=1 Participants
Participants received oral dose of 24 mg of daprodustat (6 mg\*4 tablets) once on the day of PK sampling at Week 12 or 24.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants
|
17.6522 Nanogram per milliliter
Geometric Coefficient of Variation 36.5
|
35.0709 Nanogram per milliliter
Geometric Coefficient of Variation 91.2
|
58.6098 Nanogram per milliliter
Geometric Coefficient of Variation 83.2
|
81.1851 Nanogram per milliliter
Geometric Coefficient of Variation 82.6
|
91.0731 Nanogram per milliliter
Geometric Coefficient of Variation 95.4
|
94.1242 Nanogram per milliliter
Geometric Coefficient of Variation 73.3
|
197.9290 Nanogram per milliliter
Geometric Coefficient of Variation 159.6
|
226.0000 Nanogram per milliliter
Geometric Coefficient of Variation NA
NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.
|
Adverse Events
Daprodustat in ND Participants
Serious events: 34 serious events
Other events: 85 other events
Deaths: 1 deaths
Epoetin Beta Pegol in ND Participants
Serious events: 43 serious events
Other events: 91 other events
Deaths: 2 deaths
Daprodustat in PD Participants
Serious events: 26 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daprodustat in ND Participants
n=149 participants at risk
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=150 participants at risk
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat in PD Participants
n=56 participants at risk
Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
|
|---|---|---|---|
|
Renal and urinary disorders
Renal impairment
|
3.4%
5/149 • Number of events 5 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.3%
11/150 • Number of events 11 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.0%
6/149 • Number of events 6 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
8/150 • Number of events 9 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
End stage renal disease
|
2.0%
3/149 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
3.3%
5/150 • Number of events 7 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.3%
2/150 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
2/149 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
16.1%
9/56 • Number of events 12 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Spinocerebellar disorder
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Steal syndrome
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.67%
1/150 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.67%
1/149 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
1.8%
1/56 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Daprodustat in ND Participants
n=149 participants at risk
Eligible ND participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks.
|
Epoetin Beta Pegol in ND Participants
n=150 participants at risk
Eligible ND participants received subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks.
|
Daprodustat in PD Participants
n=56 participants at risk
Eligible PD participants received oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
32.9%
49/149 • Number of events 68 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
37.3%
56/150 • Number of events 77 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
28.6%
16/56 • Number of events 23 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
5.4%
8/149 • Number of events 8 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
8/150 • Number of events 9 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
16.1%
9/56 • Number of events 15 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
8.9%
5/56 • Number of events 6 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
10/149 • Number of events 10 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
12.0%
18/150 • Number of events 19 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
12.5%
7/56 • Number of events 8 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
10.7%
6/56 • Number of events 7 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
8.9%
5/56 • Number of events 5 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
11/149 • Number of events 13 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.3%
11/150 • Number of events 13 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.1%
4/56 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.4%
11/149 • Number of events 14 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
4.7%
7/150 • Number of events 7 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
7.1%
4/56 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
12/149 • Number of events 12 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
3.3%
5/150 • Number of events 5 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
5/149 • Number of events 7 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
8/150 • Number of events 9 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood pressure increased
|
5.4%
8/149 • Number of events 8 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
2.7%
4/150 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/56 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
2.7%
4/149 • Number of events 4 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.3%
8/150 • Number of events 8 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
8.9%
5/56 • Number of events 5 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/149 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
0.00%
0/150 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
5.4%
3/56 • Number of events 3 • On-therapy serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Week 52 for both ND and PD participants.
SAEs and non-serious AEs were reported treatment-wise for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
|
Additional Information
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