Trial Outcomes & Findings for Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa (NCT NCT03799627)
NCT ID: NCT03799627
Last Updated: 2022-09-29
Results Overview
Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Baseline; Week 10 to Week 12
Results posted on
2022-09-29
Participant Flow
A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2.
Participant milestones
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
23
|
18
|
21
|
21
|
13
|
5
|
5
|
|
Overall Study
COMPLETED
|
27
|
23
|
22
|
8
|
12
|
8
|
10
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
1
|
10
|
9
|
13
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
2
|
5
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Drug Put on Hold
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Due to Urgent Safety Measures Letter
|
1
|
2
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Kidney Transplantation
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant Was on Rescue Epogen
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Placed on Dose Hold Until End of Treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Met Exclusion Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Investigational Product Noncompliance
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant Relocation
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Eurofin Issue
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Noncompliance with Site Instructions
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant's Last Dose Prior to End of Treatment
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Changes In Hemoglobin Values
|
1
|
2
|
1
|
0
|
0
|
2
|
1
|
0
|
1
|
Baseline Characteristics
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
Baseline characteristics by cohort
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
113 Participants
n=64 Participants
|
|
Age, Customized
>=65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
62 Participants
n=64 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
67 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
108 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
89 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
56 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
13 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 10 to Week 12Population: Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment.
Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
Baseline
|
10.223 grams per deciliter (g/dL)
Standard Deviation 0.5805
|
10.059 grams per deciliter (g/dL)
Standard Deviation 0.6769
|
10.165 grams per deciliter (g/dL)
Standard Deviation 0.6806
|
9.778 grams per deciliter (g/dL)
Standard Deviation 0.6832
|
10.288 grams per deciliter (g/dL)
Standard Deviation 0.5445
|
10.095 grams per deciliter (g/dL)
Standard Deviation 0.7150
|
9.950 grams per deciliter (g/dL)
Standard Deviation 0.7950
|
9.530 grams per deciliter (g/dL)
Standard Deviation 0.2864
|
9.620 grams per deciliter (g/dL)
Standard Deviation 0.6925
|
|
Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
Change from Baseline at PEP
|
-0.371 grams per deciliter (g/dL)
Standard Deviation 0.8920
|
0.072 grams per deciliter (g/dL)
Standard Deviation 1.1353
|
0.160 grams per deciliter (g/dL)
Standard Deviation 0.7519
|
-0.911 grams per deciliter (g/dL)
Standard Deviation 1.3515
|
-0.284 grams per deciliter (g/dL)
Standard Deviation 1.0383
|
-0.418 grams per deciliter (g/dL)
Standard Deviation 1.2752
|
0.268 grams per deciliter (g/dL)
Standard Deviation 1.0087
|
-0.671 grams per deciliter (g/dL)
Standard Deviation 0.7643
|
-0.290 grams per deciliter (g/dL)
Standard Deviation 1.7730
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
18 Participants
|
27 Participants
|
13 Participants
|
12 Participants
|
14 Participants
|
13 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 13 - 20Population: Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB \> 12.0 g/dL, HB \> 13.0 g/dL and HB \> 14.0 g/dL are mutually exclusive.
The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or \<8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=27 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=10 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=16 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=3 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Classified as Hb Outliers
Hb >12.0 g/dL
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified as Hb Outliers
Hb >13.0 g/dL
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified as Hb Outliers
Hb >14.0 g/dL
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Classified as Hb Outliers
Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Classified as Hb Outliers
Hb increase >1.0 g/dL within any 2-week interval
|
4 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 10 to Week 12Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=14 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=4 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hb Values Within the Target Range at the PEP
|
12 Participants
|
13 Participants
|
15 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 10 to Week 12; Week 18 to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).
Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=1 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=4 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=7 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12
|
-0.050 g/dL
Standard Deviation NA
Standard deviation cannot be calculated due to only one participant with data
|
-1.021 g/dL
Standard Deviation 1.0961
|
-0.360 g/dL
Standard Deviation 0.4894
|
-0.103 g/dL
Standard Deviation 1.9225
|
-0.422 g/dL
Standard Deviation 1.1708
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 18 to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=26 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=24 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=7 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=14 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=10 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=3 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=4 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change in Hb Between Baseline and the SEP
|
-0.197 g/dL
Standard Deviation 1.1597
|
-0.186 g/dL
Standard Deviation 0.8703
|
0.070 g/dL
Standard Deviation 0.9545
|
0.114 g/dL
Standard Deviation 1.0242
|
-0.421 g/dL
Standard Deviation 0.8370
|
-0.545 g/dL
Standard Deviation 0.9771
|
0.343 g/dL
Standard Deviation 0.8897
|
-0.283 g/dL
Standard Deviation 0.7371
|
-0.400 g/dL
Standard Deviation 1.0157
|
SECONDARY outcome
Timeframe: Week 18 to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=26 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=24 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=7 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=14 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=10 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=3 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=4 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hb Values Within the Target Range at the SEP
|
6 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 18 to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=1 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=4 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=7 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 10 to Week 12Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=14 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=4 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP
|
14 Participants
|
19 Participants
|
18 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 18 to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=26 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=24 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=7 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=14 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=10 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=12 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=3 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=4 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP
|
10 Participants
|
11 Participants
|
14 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment.
Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation
|
23 Participants
|
21 Participants
|
16 Participants
|
10 Participants
|
14 Participants
|
18 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment.
ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue
|
2 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Red Blood Cell (RBC) Transfusion
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)Population: Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis.
Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=33 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=15 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=15 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Baseline
|
7.33 Milliunits per milliliter
Geometric Coefficient of Variation 57.3
|
9.53 Milliunits per milliliter
Geometric Coefficient of Variation 54.0
|
9.93 Milliunits per milliliter
Geometric Coefficient of Variation 83.6
|
8.77 Milliunits per milliliter
Geometric Coefficient of Variation 48.2
|
6.98 Milliunits per milliliter
Geometric Coefficient of Variation 61.6
|
8.03 Milliunits per milliliter
Geometric Coefficient of Variation 53.2
|
—
|
—
|
—
|
|
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Week 1
|
12.1 Milliunits per milliliter
Geometric Coefficient of Variation 94.3
|
17.5 Milliunits per milliliter
Geometric Coefficient of Variation 97.0
|
15.3 Milliunits per milliliter
Geometric Coefficient of Variation 72.6
|
14.1 Milliunits per milliliter
Geometric Coefficient of Variation 86.4
|
20.2 Milliunits per milliliter
Geometric Coefficient of Variation 90.8
|
12.9 Milliunits per milliliter
Geometric Coefficient of Variation 54.2
|
—
|
—
|
—
|
|
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Week 1 +1 (Day 8)
|
15.6 Milliunits per milliliter
Geometric Coefficient of Variation 76.3
|
18.9 Milliunits per milliliter
Geometric Coefficient of Variation 98.2
|
16.1 Milliunits per milliliter
Geometric Coefficient of Variation 76.0
|
18.0 Milliunits per milliliter
Geometric Coefficient of Variation 49.8
|
17.4 Milliunits per milliliter
Geometric Coefficient of Variation 104.8
|
9.49 Milliunits per milliliter
Geometric Coefficient of Variation 37.1
|
—
|
—
|
—
|
|
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Week 11
|
14.2 Milliunits per milliliter
Geometric Coefficient of Variation 55.9
|
14.9 Milliunits per milliliter
Geometric Coefficient of Variation 106.2
|
19.4 Milliunits per milliliter
Geometric Coefficient of Variation 78.0
|
20.6 Milliunits per milliliter
Geometric Coefficient of Variation 169.6
|
17.3 Milliunits per milliliter
Geometric Coefficient of Variation 53.4
|
—
|
—
|
—
|
—
|
|
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Week 13
|
—
|
15.7 Milliunits per milliliter
Geometric Coefficient of Variation 107.2
|
39.2 Milliunits per milliliter
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant.
|
—
|
10.5 Milliunits per milliliter
Geometric Coefficient of Variation 47.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=32 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=21 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=20 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=11 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Reticulocyte Count
Baseline
|
51.9 10^3 cells/microliter (µL)
Standard Deviation 27.57
|
47.2 10^3 cells/microliter (µL)
Standard Deviation 17.81
|
48.8 10^3 cells/microliter (µL)
Standard Deviation 27.27
|
59.3 10^3 cells/microliter (µL)
Standard Deviation 42.02
|
48.4 10^3 cells/microliter (µL)
Standard Deviation 33.45
|
51.5 10^3 cells/microliter (µL)
Standard Deviation 25.14
|
62.6 10^3 cells/microliter (µL)
Standard Deviation 25.88
|
77.6 10^3 cells/microliter (µL)
Standard Deviation 51.04
|
83.0 10^3 cells/microliter (µL)
Standard Deviation 45.34
|
|
Mean Change From Baseline in Reticulocyte Count
Week 1
|
3.1 10^3 cells/microliter (µL)
Standard Deviation 24.09
|
6.9 10^3 cells/microliter (µL)
Standard Deviation 30.60
|
1.0 10^3 cells/microliter (µL)
Standard Deviation 22.42
|
-18.1 10^3 cells/microliter (µL)
Standard Deviation 24.81
|
-3.9 10^3 cells/microliter (µL)
Standard Deviation 28.51
|
-6.6 10^3 cells/microliter (µL)
Standard Deviation 33.80
|
20.4 10^3 cells/microliter (µL)
Standard Deviation 48.64
|
-35.8 10^3 cells/microliter (µL)
Standard Deviation 45.06
|
-25.2 10^3 cells/microliter (µL)
Standard Deviation 29.73
|
|
Mean Change From Baseline in Reticulocyte Count
Week 4
|
14.6 10^3 cells/microliter (µL)
Standard Deviation 32.25
|
14.9 10^3 cells/microliter (µL)
Standard Deviation 29.45
|
0.8 10^3 cells/microliter (µL)
Standard Deviation 40.68
|
-5.6 10^3 cells/microliter (µL)
Standard Deviation 37.38
|
2.9 10^3 cells/microliter (µL)
Standard Deviation 39.68
|
6.1 10^3 cells/microliter (µL)
Standard Deviation 33.24
|
22.5 10^3 cells/microliter (µL)
Standard Deviation 50.53
|
-26.8 10^3 cells/microliter (µL)
Standard Deviation 55.44
|
17.5 10^3 cells/microliter (µL)
Standard Deviation 26.21
|
|
Mean Change From Baseline in Reticulocyte Count
Week 8
|
14.0 10^3 cells/microliter (µL)
Standard Deviation 31.40
|
23.9 10^3 cells/microliter (µL)
Standard Deviation 39.26
|
23.1 10^3 cells/microliter (µL)
Standard Deviation 38.98
|
9.1 10^3 cells/microliter (µL)
Standard Deviation 46.38
|
20.4 10^3 cells/microliter (µL)
Standard Deviation 49.42
|
23.1 10^3 cells/microliter (µL)
Standard Deviation 20.33
|
14.0 10^3 cells/microliter (µL)
Standard Deviation 54.60
|
-3.3 10^3 cells/microliter (µL)
Standard Deviation 67.56
|
-21.8 10^3 cells/microliter (µL)
Standard Deviation 69.36
|
|
Mean Change From Baseline in Reticulocyte Count
Week 11
|
11.7 10^3 cells/microliter (µL)
Standard Deviation 25.06
|
20.2 10^3 cells/microliter (µL)
Standard Deviation 25.80
|
21.0 10^3 cells/microliter (µL)
Standard Deviation 35.12
|
26.2 10^3 cells/microliter (µL)
Standard Deviation 26.2
|
32.5 10^3 cells/microliter (µL)
Standard Deviation 70.42
|
9.2 10^3 cells/microliter (µL)
Standard Deviation 41.30
|
3.9 10^3 cells/microliter (µL)
Standard Deviation 46.15
|
-6.7 10^3 cells/microliter (µL)
Standard Deviation 76.89
|
-27.2 10^3 cells/microliter (µL)
Standard Deviation 71.36
|
|
Mean Change From Baseline in Reticulocyte Count
Week 12
|
16.1 10^3 cells/microliter (µL)
Standard Deviation 32.60
|
16.3 10^3 cells/microliter (µL)
Standard Deviation 34.27
|
22.2 10^3 cells/microliter (µL)
Standard Deviation 26.72
|
47.7 10^3 cells/microliter (µL)
Standard Deviation 66.66
|
20.3 10^3 cells/microliter (µL)
Standard Deviation 44.30
|
26.9 10^3 cells/microliter (µL)
Standard Deviation 52.64
|
4.6 10^3 cells/microliter (µL)
Standard Deviation 39.53
|
3.8 10^3 cells/microliter (µL)
Standard Deviation 52.72
|
-17.3 10^3 cells/microliter (µL)
Standard Deviation 67.06
|
|
Mean Change From Baseline in Reticulocyte Count
Week 13
|
16.7 10^3 cells/microliter (µL)
Standard Deviation 27.07
|
12.1 10^3 cells/microliter (µL)
Standard Deviation 43.12
|
16.4 10^3 cells/microliter (µL)
Standard Deviation 26.53
|
46.3 10^3 cells/microliter (µL)
Standard Deviation 57.25
|
15.9 10^3 cells/microliter (µL)
Standard Deviation 43.79
|
10.5 10^3 cells/microliter (µL)
Standard Deviation 28.80
|
0.1 10^3 cells/microliter (µL)
Standard Deviation 46.05
|
2.0 10^3 cells/microliter (µL)
Standard Deviation 83.44
|
16.3 10^3 cells/microliter (µL)
Standard Deviation 11.93
|
|
Mean Change From Baseline in Reticulocyte Count
Week 16
|
13.9 10^3 cells/microliter (µL)
Standard Deviation 35.40
|
19.6 10^3 cells/microliter (µL)
Standard Deviation 37.61
|
8.3 10^3 cells/microliter (µL)
Standard Deviation 34.16
|
-2.2 10^3 cells/microliter (µL)
Standard Deviation 57.32
|
9.7 10^3 cells/microliter (µL)
Standard Deviation 30.17
|
0.2 10^3 cells/microliter (µL)
Standard Deviation 22.08
|
26.6 10^3 cells/microliter (µL)
Standard Deviation 55.82
|
-31.5 10^3 cells/microliter (µL)
Standard Deviation 86.97
|
4.0 10^3 cells/microliter (µL)
Standard Deviation 16.21
|
|
Mean Change From Baseline in Reticulocyte Count
Week 20
|
14.5 10^3 cells/microliter (µL)
Standard Deviation 25.74
|
13.2 10^3 cells/microliter (µL)
Standard Deviation 24.50
|
23.8 10^3 cells/microliter (µL)
Standard Deviation 26.49
|
10.3 10^3 cells/microliter (µL)
Standard Deviation 41.33
|
16.4 10^3 cells/microliter (µL)
Standard Deviation 35.54
|
10.9 10^3 cells/microliter (µL)
Standard Deviation 29.81
|
38.5 10^3 cells/microliter (µL)
Standard Deviation 44.11
|
-3.3 10^3 cells/microliter (µL)
Standard Deviation 52.58
|
40.0 10^3 cells/microliter (µL)
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Iron Concentration
Baseline
|
87.4 micrograms per deciliter (µg/dL)
Standard Deviation 38.46
|
93.9 micrograms per deciliter (µg/dL)
Standard Deviation 36.56
|
90.1 micrograms per deciliter (µg/dL)
Standard Deviation 35.09
|
57.7 micrograms per deciliter (µg/dL)
Standard Deviation 26.71
|
80.9 micrograms per deciliter (µg/dL)
Standard Deviation 36.94
|
73.1 micrograms per deciliter (µg/dL)
Standard Deviation 22.23
|
65.7 micrograms per deciliter (µg/dL)
Standard Deviation 23.93
|
81.6 micrograms per deciliter (µg/dL)
Standard Deviation 37.01
|
58.4 micrograms per deciliter (µg/dL)
Standard Deviation 18.77
|
|
Mean Change From Baseline in Iron Concentration
Week 4
|
-8.0 micrograms per deciliter (µg/dL)
Standard Deviation 34.49
|
-11.2 micrograms per deciliter (µg/dL)
Standard Deviation 33.59
|
-18.3 micrograms per deciliter (µg/dL)
Standard Deviation 22.83
|
3.3 micrograms per deciliter (µg/dL)
Standard Deviation 35.23
|
9.6 micrograms per deciliter (µg/dL)
Standard Deviation 29.67
|
1.7 micrograms per deciliter (µg/dL)
Standard Deviation 23.37
|
-6.6 micrograms per deciliter (µg/dL)
Standard Deviation 32.86
|
8.6 micrograms per deciliter (µg/dL)
Standard Deviation 17.36
|
3.8 micrograms per deciliter (µg/dL)
Standard Deviation 25.79
|
|
Mean Change From Baseline in Iron Concentration
Week 8
|
-5.5 micrograms per deciliter (µg/dL)
Standard Deviation 45.04
|
-15.0 micrograms per deciliter (µg/dL)
Standard Deviation 40.51
|
-8.6 micrograms per deciliter (µg/dL)
Standard Deviation 44.30
|
4.5 micrograms per deciliter (µg/dL)
Standard Deviation 24.06
|
-5.9 micrograms per deciliter (µg/dL)
Standard Deviation 36.91
|
11.7 micrograms per deciliter (µg/dL)
Standard Deviation 40.33
|
-12.6 micrograms per deciliter (µg/dL)
Standard Deviation 26.55
|
0.3 micrograms per deciliter (µg/dL)
Standard Deviation 11.09
|
2.0 micrograms per deciliter (µg/dL)
Standard Deviation 20.33
|
|
Mean Change From Baseline in Iron Concentration
Week 12
|
-2.7 micrograms per deciliter (µg/dL)
Standard Deviation 38.24
|
-22.2 micrograms per deciliter (µg/dL)
Standard Deviation 43.14
|
-26.0 micrograms per deciliter (µg/dL)
Standard Deviation 33.03
|
-2.8 micrograms per deciliter (µg/dL)
Standard Deviation 40.49
|
-0.4 micrograms per deciliter (µg/dL)
Standard Deviation 40.20
|
-5.1 micrograms per deciliter (µg/dL)
Standard Deviation 27.54
|
-16.1 micrograms per deciliter (µg/dL)
Standard Deviation 22.88
|
-2.5 micrograms per deciliter (µg/dL)
Standard Deviation 43.94
|
-12.6 micrograms per deciliter (µg/dL)
Standard Deviation 28.99
|
|
Mean Change From Baseline in Iron Concentration
Week 16
|
-22.8 micrograms per deciliter (µg/dL)
Standard Deviation 39.39
|
-18.3 micrograms per deciliter (µg/dL)
Standard Deviation 39.85
|
-17.9 micrograms per deciliter (µg/dL)
Standard Deviation 53.89
|
-0.7 micrograms per deciliter (µg/dL)
Standard Deviation 10.26
|
5.2 micrograms per deciliter (µg/dL)
Standard Deviation 30.27
|
-4.6 micrograms per deciliter (µg/dL)
Standard Deviation 30.31
|
-13.9 micrograms per deciliter (µg/dL)
Standard Deviation 44.05
|
19.5 micrograms per deciliter (µg/dL)
Standard Deviation 53.03
|
-12.0 micrograms per deciliter (µg/dL)
Standard Deviation 24.06
|
|
Mean Change From Baseline in Iron Concentration
Week 20
|
-14.2 micrograms per deciliter (µg/dL)
Standard Deviation 41.11
|
-9.5 micrograms per deciliter (µg/dL)
Standard Deviation 27.87
|
-16.6 micrograms per deciliter (µg/dL)
Standard Deviation 46.49
|
28.7 micrograms per deciliter (µg/dL)
Standard Deviation 67.73
|
-3.1 micrograms per deciliter (µg/dL)
Standard Deviation 32.43
|
13.4 micrograms per deciliter (µg/dL)
Standard Deviation 16.03
|
-8.4 micrograms per deciliter (µg/dL)
Standard Deviation 28.94
|
-15.3 micrograms per deciliter (µg/dL)
Standard Deviation 43.19
|
-10.3 micrograms per deciliter (µg/dL)
Standard Deviation 21.57
|
SECONDARY outcome
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Ferritin Concentration
Baseline
|
939.3 micrograms per liter (µg/L)
Standard Deviation 478.64
|
1043.6 micrograms per liter (µg/L)
Standard Deviation 359.10
|
919.3 micrograms per liter (µg/L)
Standard Deviation 298.27
|
910.2 micrograms per liter (µg/L)
Standard Deviation 408.03
|
745.2 micrograms per liter (µg/L)
Standard Deviation 362.98
|
739.5 micrograms per liter (µg/L)
Standard Deviation 329.66
|
723.6 micrograms per liter (µg/L)
Standard Deviation 484.29
|
1182.2 micrograms per liter (µg/L)
Standard Deviation 508.67
|
449.6 micrograms per liter (µg/L)
Standard Deviation 423.44
|
|
Mean Change From Baseline in Ferritin Concentration
Week 4
|
-30.1 micrograms per liter (µg/L)
Standard Deviation 185.45
|
-101.9 micrograms per liter (µg/L)
Standard Deviation 204.51
|
-23.7 micrograms per liter (µg/L)
Standard Deviation 274.39
|
41.4 micrograms per liter (µg/L)
Standard Deviation 335.00
|
152.9 micrograms per liter (µg/L)
Standard Deviation 347.97
|
45.5 micrograms per liter (µg/L)
Standard Deviation 320.50
|
-145.6 micrograms per liter (µg/L)
Standard Deviation 211.10
|
34.8 micrograms per liter (µg/L)
Standard Deviation 470.43
|
-61.5 micrograms per liter (µg/L)
Standard Deviation 17.37
|
|
Mean Change From Baseline in Ferritin Concentration
Week 8
|
-120.8 micrograms per liter (µg/L)
Standard Deviation 273.28
|
-185.4 micrograms per liter (µg/L)
Standard Deviation 298.19
|
24.9 micrograms per liter (µg/L)
Standard Deviation 334.28
|
29.4 micrograms per liter (µg/L)
Standard Deviation 361.29
|
-5.6 micrograms per liter (µg/L)
Standard Deviation 255.10
|
-87.8 micrograms per liter (µg/L)
Standard Deviation 285.30
|
-78.3 micrograms per liter (µg/L)
Standard Deviation 254.98
|
111.3 micrograms per liter (µg/L)
Standard Deviation 609.61
|
397.8 micrograms per liter (µg/L)
Standard Deviation 453.76
|
|
Mean Change From Baseline in Ferritin Concentration
Week 12
|
-118.5 micrograms per liter (µg/L)
Standard Deviation 220.40
|
-194.8 micrograms per liter (µg/L)
Standard Deviation 288.47
|
-42.4 micrograms per liter (µg/L)
Standard Deviation 356.19
|
-68.0 micrograms per liter (µg/L)
Standard Deviation 275.11
|
-23.8 micrograms per liter (µg/L)
Standard Deviation 303.39
|
-30.1 micrograms per liter (µg/L)
Standard Deviation 386.24
|
-195.3 micrograms per liter (µg/L)
Standard Deviation 304.63
|
-0.5 micrograms per liter (µg/L)
Standard Deviation 237.99
|
-35.0 micrograms per liter (µg/L)
Standard Deviation 157.46
|
|
Mean Change From Baseline in Ferritin Concentration
Week 16
|
-92.0 micrograms per liter (µg/L)
Standard Deviation 309.88
|
-70.9 micrograms per liter (µg/L)
Standard Deviation 288.34
|
99.5 micrograms per liter (µg/L)
Standard Deviation 567.19
|
-144.0 micrograms per liter (µg/L)
Standard Deviation 358.78
|
27.8 micrograms per liter (µg/L)
Standard Deviation 244.67
|
-97.2 micrograms per liter (µg/L)
Standard Deviation 188.15
|
-81.8 micrograms per liter (µg/L)
Standard Deviation 447.01
|
80.0 micrograms per liter (µg/L)
Standard Deviation 243.24
|
62.3 micrograms per liter (µg/L)
Standard Deviation 186.15
|
|
Mean Change From Baseline in Ferritin Concentration
Week 20
|
-113.6 micrograms per liter (µg/L)
Standard Deviation 327.06
|
-166.6 micrograms per liter (µg/L)
Standard Deviation 298.67
|
26.5 micrograms per liter (µg/L)
Standard Deviation 497.52
|
-199.4 micrograms per liter (µg/L)
Standard Deviation 370.32
|
4.8 micrograms per liter (µg/L)
Standard Deviation 331.76
|
-51.6 micrograms per liter (µg/L)
Standard Deviation 253.07
|
-104.8 micrograms per liter (µg/L)
Standard Deviation 347.53
|
249.0 micrograms per liter (µg/L)
Standard Deviation 636.33
|
607.0 micrograms per liter (µg/L)
Standard Deviation 607.0
|
SECONDARY outcome
Timeframe: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Iron Binding Capacity
Baseline
|
237.8 µg/dL
Standard Deviation 39.28
|
230.7 µg/dL
Standard Deviation 39.09
|
234.8 µg/dL
Standard Deviation 44.76
|
210.1 µg/dL
Standard Deviation 33.33
|
235.7 µg/dL
Standard Deviation 38.80
|
223.6 µg/dL
Standard Deviation 34.31
|
218.2 µg/dL
Standard Deviation 33.80
|
211.0 µg/dL
Standard Deviation 42.99
|
225.6 µg/dL
Standard Deviation 98.15
|
|
Mean Change From Baseline in Total Iron Binding Capacity
Week 4
|
35.9 µg/dL
Standard Deviation 27.11
|
27.7 µg/dL
Standard Deviation 33.58
|
-13.4 µg/dL
Standard Deviation 26.02
|
27.6 µg/dL
Standard Deviation 28.49
|
41.0 µg/dL
Standard Deviation 26.22
|
48.2 µg/dL
Standard Deviation 37.78
|
-0.5 µg/dL
Standard Deviation 21.44
|
44.2 µg/dL
Standard Deviation 53.58
|
7.8 µg/dL
Standard Deviation 14.38
|
|
Mean Change From Baseline in Total Iron Binding Capacity
Week 8
|
30.3 µg/dL
Standard Deviation 28.42
|
37.0 µg/dL
Standard Deviation 40.99
|
-1.1 µg/dL
Standard Deviation 18.38
|
26.3 µg/dL
Standard Deviation 23.98
|
49.4 µg/dL
Standard Deviation 27.34
|
58.8 µg/dL
Standard Deviation 24.54
|
-7.4 µg/dL
Standard Deviation 19.26
|
56.0 µg/dL
Standard Deviation 58.15
|
-24.8 µg/dL
Standard Deviation 58.79
|
|
Mean Change From Baseline in Total Iron Binding Capacity
Week 12
|
42.4 µg/dL
Standard Deviation 27.10
|
37.2 µg/dL
Standard Deviation 43.09
|
-9.9 µg/dL
Standard Deviation 25.85
|
25.1 µg/dL
Standard Deviation 33.90
|
41.0 µg/dL
Standard Deviation 39.05
|
54.5 µg/dL
Standard Deviation 44.05
|
-3.8 µg/dL
Standard Deviation 25.42
|
58.0 µg/dL
Standard Deviation 14.45
|
-0.6 µg/dL
Standard Deviation 15.32
|
|
Mean Change From Baseline in Total Iron Binding Capacity
Week 16
|
35.0 µg/dL
Standard Deviation 43.00
|
27.8 µg/dL
Standard Deviation 35.16
|
-3.0 µg/dL
Standard Deviation 25.44
|
55.3 µg/dL
Standard Deviation 28.63
|
53.1 µg/dL
Standard Deviation 58.33
|
60.9 µg/dL
Standard Deviation 70.50
|
-13.7 µg/dL
Standard Deviation 31.46
|
42.5 µg/dL
Standard Deviation 62.93
|
-2.5 µg/dL
Standard Deviation 18.52
|
|
Mean Change From Baseline in Total Iron Binding Capacity
Week 20
|
38.0 µg/dL
Standard Deviation 28.15
|
44.9 µg/dL
Standard Deviation 30.71
|
-9.5 µg/dL
Standard Deviation 29.29
|
51.7 µg/dL
Standard Deviation 37.50
|
68.4 µg/dL
Standard Deviation 43.40
|
67.9 µg/dL
Standard Deviation 58.44
|
-5.4 µg/dL
Standard Deviation 29.78
|
66.7 µg/dL
Standard Deviation 35.22
|
-6.0 µg/dL
Standard Deviation 21.79
|
SECONDARY outcome
Timeframe: Baseline; Week 12 and Week 20Population: Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=35 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=34 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=21 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=17 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 Participants
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 Participants
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Hepcidin Concentration
Baseline
|
194.870 nanograms per milliliter (ng/mL)
Standard Deviation 113.9348
|
208.816 nanograms per milliliter (ng/mL)
Standard Deviation 85.1667
|
259.161 nanograms per milliliter (ng/mL)
Standard Deviation 134.9995
|
185.852 nanograms per milliliter (ng/mL)
Standard Deviation 105.6611
|
215.608 nanograms per milliliter (ng/mL)
Standard Deviation 130.7350
|
160.760 nanograms per milliliter (ng/mL)
Standard Deviation 102.6261
|
143.519 nanograms per milliliter (ng/mL)
Standard Deviation 124.6749
|
239.958 nanograms per milliliter (ng/mL)
Standard Deviation 151.3859
|
74.748 nanograms per milliliter (ng/mL)
Standard Deviation 40.2119
|
|
Mean Change From Baseline in Hepcidin Concentration
Week 12
|
-50.565 nanograms per milliliter (ng/mL)
Standard Deviation 57.6474
|
-53.675 nanograms per milliliter (ng/mL)
Standard Deviation 92.1185
|
-66.646 nanograms per milliliter (ng/mL)
Standard Deviation 152.3178
|
-55.283 nanograms per milliliter (ng/mL)
Standard Deviation 77.1648
|
-34.868 nanograms per milliliter (ng/mL)
Standard Deviation 89.7176
|
-74.797 nanograms per milliliter (ng/mL)
Standard Deviation 126.1667
|
-62.787 nanograms per milliliter (ng/mL)
Standard Deviation 96.1842
|
-128.587 nanograms per milliliter (ng/mL)
Standard Deviation 262.6300
|
-1.062 nanograms per milliliter (ng/mL)
Standard Deviation 30.4842
|
|
Mean Change From Baseline in Hepcidin Concentration
Week 20
|
-86.025 nanograms per milliliter (ng/mL)
Standard Deviation 100.4382
|
-38.627 nanograms per milliliter (ng/mL)
Standard Deviation 75.0555
|
-83.685 nanograms per milliliter (ng/mL)
Standard Deviation 95.7049
|
-93.412 nanograms per milliliter (ng/mL)
Standard Deviation 115.2839
|
-83.012 nanograms per milliliter (ng/mL)
Standard Deviation 98.7521
|
-43.701 nanograms per milliliter (ng/mL)
Standard Deviation 80.8411
|
-80.680 nanograms per milliliter (ng/mL)
Standard Deviation 125.2481
|
-152.243 nanograms per milliliter (ng/mL)
Standard Deviation 218.9284
|
-9.023 nanograms per milliliter (ng/mL)
Standard Deviation 80.4001
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=32 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=14 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Week 1
|
26.0 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 87.9
|
40.8 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 54.8
|
26.5 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 59.3
|
47.0 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 38.2
|
56.5 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 39.2
|
44.2 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 73.1
|
—
|
—
|
—
|
|
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
20.1 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 174.4
|
37.6 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 78.9
|
23.8 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 69.0
|
44.2 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 29.6
|
60.1 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 41.6
|
31.6 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 151.6
|
—
|
—
|
—
|
|
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Week 11
|
28.6 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 49.3
|
24.4 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 350.6
|
32.4 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 26.9
|
38.1 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 99.0
|
41.2 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 77.7
|
—
|
—
|
—
|
—
|
|
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Week 13
|
—
|
30.6 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 102.7
|
11.5 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant
|
—
|
60.2 Micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 9.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=29 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=28 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
Week 1
|
338 hours*µg/mL
Geometric Coefficient of Variation 63.8
|
518 hours*µg/mL
Geometric Coefficient of Variation 71.1
|
342 hours*µg/mL
Geometric Coefficient of Variation 81.7
|
605 hours*µg/mL
Geometric Coefficient of Variation 54.5
|
786 hours*µg/mL
Geometric Coefficient of Variation 36.6
|
464 hours*µg/mL
Geometric Coefficient of Variation 80.9
|
—
|
—
|
—
|
|
Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
289 hours*µg/mL
Geometric Coefficient of Variation 76.6
|
465 hours*µg/mL
Geometric Coefficient of Variation 80.8
|
310 hours*µg/mL
Geometric Coefficient of Variation 94.7
|
566 hours*µg/mL
Geometric Coefficient of Variation 41.1
|
847 hours*µg/mL
Geometric Coefficient of Variation 54.8
|
388 hours*µg/mL
Geometric Coefficient of Variation 112.4
|
—
|
—
|
—
|
|
Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
Week 11
|
344 hours*µg/mL
Geometric Coefficient of Variation 53.5
|
338 hours*µg/mL
Geometric Coefficient of Variation 282.0
|
402 hours*µg/mL
Geometric Coefficient of Variation 70.8
|
450 hours*µg/mL
Geometric Coefficient of Variation 68.2
|
588 hours*µg/mL
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=17 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=8 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=8 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=6 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=2 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Week 1
|
8.53 Hours
Interval 5.36 to 26.6
|
10.5 Hours
Interval 3.26 to 21.1
|
12.5 Hours
Interval 7.33 to 20.7
|
10.3 Hours
Interval 6.33 to 18.3
|
11.0 Hours
Interval 6.51 to 18.0
|
9.01 Hours
Interval 8.45 to 9.58
|
—
|
—
|
—
|
|
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
8.82 Hours
Interval 5.8 to 22.9
|
8.83 Hours
Interval 4.98 to 70.0
|
10.1 Hours
Interval 4.79 to 17.9
|
12.4 Hours
Interval 5.73 to 47.8
|
14.6 Hours
Interval 5.61 to 31.3
|
11.7 Hours
Interval 11.3 to 12.0
|
—
|
—
|
—
|
|
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Week 11
|
6.73 Hours
Interval 3.55 to 22.1
|
10.4 Hours
Interval 6.46 to 13.8
|
6.49 Hours
Interval 3.22 to 9.75
|
3.95 Hours
Interval 3.95 to 3.95
|
5.65 Hours
Interval 5.26 to 7.12
|
—
|
—
|
—
|
—
|
|
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Week 13
|
—
|
11.0 Hours
Interval 11.0 to 11.0
|
—
|
—
|
5.01 Hours
Interval 5.01 to 5.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=32 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=30 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=14 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Week 1
|
2.08 Hours
Interval 0.0 to 11.5
|
2.72 Hours
Interval 1.83 to 5.03
|
3.48 Hours
Interval 1.92 to 10.5
|
3.50 Hours
Interval 1.58 to 9.0
|
2.00 Hours
Interval 1.75 to 5.03
|
3.28 Hours
Interval 1.83 to 4.5
|
—
|
—
|
—
|
|
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
3.28 Hours
Interval 1.75 to 6.75
|
2.11 Hours
Interval 0.0 to 5.23
|
3.33 Hours
Interval 1.8 to 5.0
|
3.30 Hours
Interval 0.0 to 5.0
|
2.17 Hours
Interval 1.75 to 5.05
|
3.42 Hours
Interval 1.8 to 4.5
|
—
|
—
|
—
|
|
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Week 11
|
3.23 Hours
Interval 0.0 to 4.5
|
3.50 Hours
Interval 1.75 to 10.83
|
3.50 Hours
Interval 2.0 to 4.67
|
2.03 Hours
Interval 1.75 to 3.63
|
2.11 Hours
Interval 1.8 to 5.0
|
—
|
—
|
—
|
—
|
|
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Week 13
|
—
|
1.98 Hours
Interval 1.75 to 5.0
|
4.25 Hours
Interval 4.25 to 4.25
|
—
|
2.04 Hours
Interval 1.97 to 2.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=17 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=17 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=8 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=8 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=6 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=2 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Week 1
|
0.0797 1/hour
Geometric Coefficient of Variation 38.7
|
0.0665 1/hour
Geometric Coefficient of Variation 50.5
|
0.0560 1/hour
Geometric Coefficient of Variation 41.6
|
0.0681 1/hour
Geometric Coefficient of Variation 32.7
|
0.0608 1/hour
Geometric Coefficient of Variation 46.9
|
0.0771 1/hour
Geometric Coefficient of Variation 8.9
|
—
|
—
|
—
|
|
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
0.0720 1/hour
Geometric Coefficient of Variation 44.2
|
0.0615 1/hour
Geometric Coefficient of Variation 70.0
|
0.0714 1/hour
Geometric Coefficient of Variation 53.9
|
0.0469 1/hour
Geometric Coefficient of Variation 72.2
|
0.0469 1/hour
Geometric Coefficient of Variation 74.4
|
0.0594 1/hour
Geometric Coefficient of Variation 4.5
|
—
|
—
|
—
|
|
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Week 11
|
0.0925 1/hour
Geometric Coefficient of Variation 65.5
|
0.0687 1/hour
Geometric Coefficient of Variation 26.5
|
0.124 1/hour
Geometric Coefficient of Variation 92.0
|
0.175 1/hour
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant
|
0.116 1/hour
Geometric Coefficient of Variation 15.9
|
—
|
—
|
—
|
—
|
|
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Week 13
|
—
|
0.0632 1/hour
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant
|
—
|
—
|
0.138 1/hour
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=29 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=28 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=13 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=21 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=13 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=5 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
Week 1
|
0.888 liters per hour
Geometric Coefficient of Variation 63.8
|
0.869 liters per hour
Geometric Coefficient of Variation 71.1
|
0.877 liters per hour
Geometric Coefficient of Variation 81.7
|
0.744 liters per hour
Geometric Coefficient of Variation 54.5
|
0.763 liters per hour
Geometric Coefficient of Variation 36.6
|
1.29 liters per hour
Geometric Coefficient of Variation 80.9
|
—
|
—
|
—
|
|
Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
1.04 liters per hour
Geometric Coefficient of Variation 76.6
|
0.967 liters per hour
Geometric Coefficient of Variation 80.8
|
0.968 liters per hour
Geometric Coefficient of Variation 94.7
|
0.795 liters per hour
Geometric Coefficient of Variation 41.1
|
0.708 liters per hour
Geometric Coefficient of Variation 54.8
|
1.55 liters per hour
Geometric Coefficient of Variation 112.4
|
—
|
—
|
—
|
|
Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
Week 11
|
0.872 liters per hour
Geometric Coefficient of Variation 53.5
|
1.33 liters per hour
Geometric Coefficient of Variation 282.0
|
0.747 liters per hour
Geometric Coefficient of Variation 70.8
|
1.00 liters per hour
Geometric Coefficient of Variation 68.2
|
1.02 liters per hour
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dosePopulation: PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
Outcome measures
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=16 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=15 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=8 Participants
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=8 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=6 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=2 Participants
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Week 1 +1 (Day 8)
|
12.5 Liters
Geometric Coefficient of Variation 36.6
|
13.7 Liters
Geometric Coefficient of Variation 41.0
|
17.4 Liters
Geometric Coefficient of Variation 50.4
|
15.3 Liters
Geometric Coefficient of Variation 67.4
|
15.6 Liters
Geometric Coefficient of Variation 27.2
|
12.4 Liters
Geometric Coefficient of Variation 35.8
|
—
|
—
|
—
|
|
Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Week 11
|
10.2 Liters
Geometric Coefficient of Variation 28.7
|
10.7 Liters
Geometric Coefficient of Variation 37.6
|
10.1 Liters
Geometric Coefficient of Variation 10.3
|
8.24 Liters
Geometric Coefficient of Variation NA
Dispersion data are not available for a single participant
|
8.76 Liters
Geometric Coefficient of Variation 18.9
|
—
|
—
|
—
|
—
|
|
Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Week 1
|
10.9 Liters
Geometric Coefficient of Variation 36.2
|
14.3 Liters
Geometric Coefficient of Variation 53.4
|
13.7 Liters
Geometric Coefficient of Variation 69.7
|
12.1 Liters
Geometric Coefficient of Variation 38.6
|
13.8 Liters
Geometric Coefficient of Variation 16.7
|
15.8 Liters
Geometric Coefficient of Variation 56.9
|
—
|
—
|
—
|
Adverse Events
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Low Dose of Epoetin Alfa: Epoetin Alfa
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
High Dose of Epoetin Alfa: Vadadustat 300 mg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 1 deaths
High Dose of Epoetin Alfa: Vadadustat 450 mg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
High Dose of Epoetin Alfa: Vadadustat 600 mg
Serious events: 10 serious events
Other events: 10 other events
Deaths: 1 deaths
High Dose of Epoetin Alfa: Epoetin Alfa
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
ESA Hyporesponder: Vadadustat 600 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
ESA Hyporesponder: Epoetin Alfa
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=35 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 participants at risk
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 participants at risk
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Acute left ventricular failure
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.7%
2/23 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Death
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Gangrene
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Localised infection
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Sepsis
|
5.9%
2/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
40.0%
2/5 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Seizure
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Reproductive system and breast disorders
Nipple pain
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Surgical and medical procedures
Pancreas transplant
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypertensive urgency
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
Other adverse events
| Measure |
Low Dose of Epoetin Alfa: Vadadustat 300 mg
n=34 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week \[U/kg/week\]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Vadadustat 450 mg
n=35 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
Low Dose of Epoetin Alfa: Epoetin Alfa
n=23 participants at risk
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
High Dose of Epoetin Alfa: Vadadustat 300 mg
n=18 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 450 mg
n=21 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Vadadustat 600 mg
n=21 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
High Dose of Epoetin Alfa: Epoetin Alfa
n=13 participants at risk
Participants who were maintained on the high dose of Epoetin Alfa (\>90 to \<300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
ESA Hyporesponder: Vadadustat 600 mg
n=5 participants at risk
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
|
ESA Hyporesponder: Epoetin Alfa
n=5 participants at risk
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Right atrial enlargement
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Eye disorders
Cataract
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.7%
2/35 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.6%
3/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
17.4%
4/23 • Number of events 5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
22.2%
4/18 • Number of events 4 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
9.5%
2/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
19.0%
4/21 • Number of events 4 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
11.1%
2/18 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Asthenia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.7%
2/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
9.5%
2/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Pain
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.6%
3/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Pyrexia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Influenza
|
5.9%
2/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Localised infection
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Nail infection
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.6%
3/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.6%
3/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
9.5%
2/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.7%
2/23 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
11.1%
2/18 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Investigations
Weight decreased
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
11.1%
2/18 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
14.3%
3/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
11.1%
2/18 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.7%
2/35 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
14.3%
3/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.7%
2/35 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.7%
2/23 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
2.9%
1/35 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.7%
2/35 • Number of events 2 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.3%
1/23 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Skin and subcutaneous tissue disorders
Uraemic pruritus
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Haematoma
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
8.6%
3/35 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/18 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
4.8%
1/21 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
14.3%
3/21 • Number of events 3 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
7.7%
1/13 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
20.0%
1/5 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
|
Vascular disorders
Vascular calcification
|
0.00%
0/34 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/35 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/23 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
5.6%
1/18 • Number of events 1 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/21 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/13 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
0.00%
0/5 • Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place